510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Laserpro 810, 940 and 980 Diode Laser Systems

K082721510(k) TraditionalCleared Oct 28, 200841-day reviewClass II21 CFR 878.4810Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Photo Medex, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Oct 28, 2008 as substantially equivalent to K042211 (Surgical Laser Technologies, Inc., 2004) and 11 other predicates after a 41-day review. Its family tree reaches back 16 generations to 1995. 7 later devices descend from it. It has been recalled once.

Decided
Oct 28, 2008
Review
41 days
Class
Class II
Product code
GEX
Recalls
1
Predicates
12

Its longest line of descent runs back 16 generations to K943450 (1995). 358 ancestors in all, the oldest K771218 (1978). 7 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 4 other ancestors2007: 2 other ancestors2006: 6 other ancestors2004: 19 other ancestors2000: 31 other ancestors1995: 16 other ancestors2002: 36 other ancestors1999: 22 other ancestors1998: 25 other ancestors1997: 27 other ancestors2005: 12 other ancestors2003: 32 other ancestors2001: 29 other ancestors1996: 24 other ancestors1994: 18 other ancestors1993: 12 other ancestors1992: 6 other ancestors1991: 7 other ancestors1990: 2 other ancestors1989: 3 other ancestors1981: 1 other ancestor1978: 1 other ancestor1988: 2 other ancestors1987: 2 other ancestors1982: 1 other ancestor1980: 1 other ancestor1985: 1 other ancestor2009: 1 descendant cleared2024: 1 descendant cleared2010: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2025: 1 descendant cleared2018: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K053616 · Polaris WR, ST Applicator · Syneron Medical, Ltd. · 2006K070388 · Profile Multi-Platform System · Sciton, Inc · 2007×2: 2 generations cleared close together, K080567 (2008), K081416 (2008) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 10 other ancestors2 generations back: 11 other ancestors3 generations back: 25 other ancestors4 generations back: 51 other ancestors5 generations back: 89 other ancestors6 generations back: 95 other ancestors7 generations back: 48 other ancestors8 generations back: 12 other ancestors9 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 3 descendants K081416 · Palomar Aspire Laser Platform · Palomar Medical Products, Inc. · 2008K080567 · Palomar Aspire Laser Platform · Palomar Medical Products, Inc. · 2008K070388 · Profile Multi-Platform System · Sciton, Inc · 2007K053616 · Polaris WR, ST Applicator · Syneron Medical, Ltd. · 2006K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−15−10−50
  1. Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 12 generations between
  3. 3 generations backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
  4. 2 generations backK080567 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
  5. 1 generation backK081416 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
  6. This deviceK082721 Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 2008
  7. Descendant · cites it directly · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
  8. Descendant · 2 generations on · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
  9. Descendant · cites it directly · 0 of its ownK243141 Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D…Jiangxi Medex Technology Co., Ltd. · 2024
  10. Descendant · 2 generations on · 0 of its ownK191349 980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019
  11. Descendant · 2 generations on · 0 of its ownK173067 LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC · 2018
Show all 16 generations
  1. Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 4 generations backK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
  14. 3 generations backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
  15. 2 generations backK080567 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
  16. 1 generation backK081416 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
  17. This deviceK082721 Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 2008

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12015: 12018: 12019: 12024: 12025: 1
2009high 1 (2009) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · See all
  • K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015 · cites it directly3descendants
  • K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd. · 2025 · 2 generations on0descendants
  • K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd. · 2024 · cites it directly0descendants
  • K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019 · 2 generations on0descendants
  • K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−15K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−14K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−13K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−12K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−11K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−10K000944Thermage Thermacool SystemThermage, Inc.2000—
−9K013034Modification to: Thermacool IiaThermage, Inc.2001—
−8K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−7K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−6K030142Thermacool TC SystemThermage, Inc.2003—
−5K031671Polaris WRSyneron Medical, Ltd.2003—
−4K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006—
−3K070388Profile Multi-Platform SystemSciton, Inc2007—
−2K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.2008—
−1K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.2008—
0 (this device)K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.2008—
+1K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.2015—
+2K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems…Wuhan Dimed Laser Technology Co., Ltd.2025—
+1K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810)…Jiangxi Medex Technology Co., Ltd.2024—
+2K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.2019—
+2K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198010
198110
198210
198510
198720
198820
198930
199020
199170
199260
1993120
1994180
1995160
1996240
1997270
1998250
1999220
2000310
2001290
2002360
2003320
2004190
2005120
200660
200720
200840

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201510
201810
201910
202410
202510
FIG. 1 — Lineage of K082721, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

  1. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (12)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems
Summary page 1
…e Surgical Laser System 3. PREDICATE DEVICES Diode Surgical Laser Systems * PhotoMedex LaserPro 810, 940 & 980 Surgical Diode Laser Systems: Cleared via K042211, K040294 · Biolitec Ceralas D980 (Models D15, D25): Cleared via K072779 • CeramOptec Ceralas (Models D10-60): Cleared…
Surgical Laser Technologies, Inc.2004—
*K040294Laserpro Diode Laser Systems, Models 810, 940 & 980
Summary page 1
…l Laser System 3. PREDICATE DEVICES Diode Surgical Laser Systems * PhotoMedex LaserPro 810, 940 & 980 Surgical Diode Laser Systems: Cleared via K042211, K040294 · Biolitec Ceralas D980 (Models D15, D25): Cleared via K072779 • CeramOptec Ceralas (Models D10-60): Cleared via K001…
Photo Medex, Inc.2004—
*K072779Ceralas D 980NM Diode Laser, Models D15 and D25
Summary page 1
…* PhotoMedex LaserPro 810, 940 & 980 Surgical Diode Laser Systems: Cleared via K042211, K040294 · Biolitec Ceralas D980 (Models D15, D25): Cleared via K072779 • CeramOptec Ceralas (Models D10-60): Cleared via K001975 · B&W Tek BWF-5 Medical Laser Series: Cleared via K062363…
Biolitec, Inc.2008—
*K001975Ceralas D10 810NM Laser, Model Ceralas D10-60
Summary page 1
…ystems: Cleared via K042211, K040294 · Biolitec Ceralas D980 (Models D15, D25): Cleared via K072779 • CeramOptec Ceralas (Models D10-60): Cleared via K001975 · B&W Tek BWF-5 Medical Laser Series: Cleared via K062363 * Premier Aurora Laser System: Cleared via K954316 *…
Ceram Optec, Inc.2000—
*K062363BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NM
Summary page 1
…ralas D980 (Models D15, D25): Cleared via K072779 • CeramOptec Ceralas (Models D10-60): Cleared via K001975 · B&W Tek BWF-5 Medical Laser Series: Cleared via K062363 * Premier Aurora Laser System: Cleared via K954316 * SLT Thermalite 810, 940, & 980 Laser Systems: Cleared via K95266…
B&W Tek, Inc.2007—
*K954316Aurora Surgical Diode Laser System W/Accessories
Summary page 1
…CeramOptec Ceralas (Models D10-60): Cleared via K001975 · B&W Tek BWF-5 Medical Laser Series: Cleared via K062363 * Premier Aurora Laser System: Cleared via K954316 * SLT Thermalite 810, 940, & 980 Laser Systems: Cleared via K952661 * Osyris Pharaon Lipo : Cleared via K073617 ·…
Premier Laser Systems, Inc.1995—
*K952661SLT Thermalite Diode Laser Series, Diode 980, 810, 940
Summary page 1
…WF-5 Medical Laser Series: Cleared via K062363 * Premier Aurora Laser System: Cleared via K954316 * SLT Thermalite 810, 940, & 980 Laser Systems: Cleared via K952661 * Osyris Pharaon Lipo : Cleared via K073617 · Palomar Aspire: Cleared via K080567, K081416 Other Laser Systems…
Surgical Laser Technologies, Inc.1995—
*K073617Pharaon Lipo
Summary page 1
…* Premier Aurora Laser System: Cleared via K954316 * SLT Thermalite 810, 940, & 980 Laser Systems: Cleared via K952661 * Osyris Pharaon Lipo : Cleared via K073617 · Palomar Aspire: Cleared via K080567, K081416 Other Laser Systems * Cynosure SmartLipo ND:YAG Laser System: Cleare…
Osyris2008—
*K080567Palomar Aspire Laser Platform
Summary page 1
…a K954316 * SLT Thermalite 810, 940, & 980 Laser Systems: Cleared via K952661 * Osyris Pharaon Lipo : Cleared via K073617 · Palomar Aspire: Cleared via K080567, K081416 Other Laser Systems * Cynosure SmartLipo ND:YAG Laser System: Cleared via K062321 * New Star Lasers, Inc C…
Palomar Medical Products, Inc.2008—
*K081416Palomar Aspire Laser Platform
Summary page 1
…* SLT Thermalite 810, 940, & 980 Laser Systems: Cleared via K952661 * Osyris Pharaon Lipo : Cleared via K073617 · Palomar Aspire: Cleared via K080567, K081416 Other Laser Systems * Cynosure SmartLipo ND:YAG Laser System: Cleared via K062321 * New Star Lasers, Inc CoolTouch…
Palomar Medical Products, Inc.2008—
*K062321Smartlipo ND:Yag Laser
Summary page 1
…Pharaon Lipo : Cleared via K073617 · Palomar Aspire: Cleared via K080567, K081416 Other Laser Systems * Cynosure SmartLipo ND:YAG Laser System: Cleared via K062321 * New Star Lasers, Inc CoolTouch NS160 Nd:Yag Surgical Laser: Cleared via K072751…
Cynosure, Inc.2006—
*K072751Cooltouch Models NS 160 and LC215 Coolipo
Summary page 1
…aser Systems * Cynosure SmartLipo ND:YAG Laser System: Cleared via K062321 * New Star Lasers, Inc CoolTouch NS160 Nd:Yag Surgical Laser: Cleared via K072751 XIV-2 Tradiiionai 51O(h), Device Modifica tion Amenracit' ,…
New Star Lasers, Inc.2008—

Also cleared against K042211: 2 other devices →

What descends from it? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153
K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240
K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100
K091059Foxq 980 LaserA.R.C Laser GmbH20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 4, 2013Class IIZ-0005-2014Process change controlFirm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 6 companies; a new generation was cleared every 9 months on median.
  • 18 of the 358 ancestors have a recall of any class.
  • Of its descendants, K151890 (Wuhan Gigaa Optronics Technology Co., Ltd., 2015) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K042211.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology…

Read the full statement (952 words)

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only).

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems, (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: orthopedics.

The PhotoMedex LaserPro 810, 940 and 980 Surgical Diode Laser Systems are indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, orthopedics, arthroscopy, podiatry, pulmonology, and thoracic surgery; and Laser Assisted Lipolysis (980 nm only) as follow:

Gastroenteroloay

The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in gastroenterology procedures. Applications include:

- hemostasis of esophageal varices;

- palliation of malignant dysphagia;

- palliative ablation of obstructive neoplasms;

- hemostasis of colonoscopy.

- hemostasis of upper and lower GI bleeding (810 nm or 980 nm only);

- excision and vaporization of colorectal carcinoma (810 nm or 980 nm only);

- excision of polyps (810 nm or 980 nm only).

Continued from previous page:

Neurosurgery

The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include:

- tumors adjacent to the spinal cord;

- tumors adjacent to the cortex.

General Surgery, Aesthetic (Dermatology and Plastic Surgery), and Podiatry

Treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein.

The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include:

Laparoscopic

- appendectomy;

- cholecystectomy;

- bowel resection.

Open

- mastectomy;

- reduction mammoplasty;

- breast biopsy;

- rectal and anal hemorrhoidectomy;

- bowel resection;

- colectomy;

- cholecystectomy;

- liver resection;

- condyloma;

- thyroidectomy;

Continued from previous page:

- thoracotomy;

- cavernous hemangioma;

Open (810 nm or 980 nm only)

- matrixectomy;

- excision of neuromas;

- excision of perifungual & subungual warts;

- excision of plantar warts;

- excision of keloids

- excision of cutaneous lesions;

- debridement of decubitus ulcer;

- hepatobillary tumors;

- dermabrasion;

- vaporization & hemostasis of capillary hemangioma;

- excision, vaporization, & hemostasis of abdominal tumors;

- excision, vaporization & hemostasis of rectal pathology;

- pilondial cystectomy;

- hemiorrhaphy;

- adhesiolysis;

- parathyroidectomy;

- thyroidectomy;

- resection of organs;

- debridement of wounds

- photocoagulation of telangiectasia of the legs and face;

- photocoagulation of vascular lesions of the face and extremities.

Continued from previous page:

Genitourinary (Urology)

The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include:

- Transurethral

- transurethral incision of the prostate (TUlIP);

- bladder tumors;

- bladder neck incisions;

- removal of bladder neck obstructions (810 nm or 980 nm only);

- urethral strictures;

- exterior sphincterotomy.

- vaporization of urethral tumors (810 nm or 980 nm only).

- Laparoscopic

- lymphadenectomy.

- Open

- condyloma;

- circumcision

- benign and malignant lesions of external genitalia.

Thoracic Surgery

The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include:

- pulmonary resection;

- coagulation of blebs and bullae;

- adhesiolysis;

- pericardiectomy

- mediastinal and thoracic lesions and abnormalities;

- mediastinal lymph node dissection;

- thoracotomy.

Continued from previous page:

Gynecology (GYN)

The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include:

- Laparoscopic

- excision/lysis of adhesions;

- endometrial lesions, including ablation of endometriosis;

- laparoscopic assisted hysterectomy (LAVH);

- laser uterosacral nerve ablation (LUNA);

- myomectomy;

- ovarian cystectomy;

- ovarian drilling;

- tubal fimbrioplasty;

- appendectomy;

- menorrhagia (810 nm or 980 nm only).

- Open

- conization of the cervix, including cervical intraepithelial neoplasia (GIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN;

- condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions.

- Intrauterine

- fibroids/polyps/adhesions;

- resection of septum.

Continued from previous page:

Pulmonology

The, hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include:

- tracheal bronchial lesions.

- tracheobronchial malignancy or stricture; (810 nm or 980 nm only)

- benign and malignant pulmonary obstruction; (810 nm or 980 nm only)

- endoscopic pulmonary applications. (810 nm or 980 nm only)

Ophthalmology

The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include:

- Oculoplastics

- open DCR;

- endo-nasal DCR;

- tumor excision and biopsy;

- eyelid reconstruction;

- blepharoplasty.

Orthopedics

The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures and arthroscopy; and the hemostasis of soft tissue in arthroscopy. Applications include:

- Open

- dissect and coagulate.

Continued from previous page:

Otolaryngology (ENT)

The hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include:

- Nasal/Sinus

- turbinectomy and turbinate reduction/ablation;

- polypectomy of nose and nasal passages;

- ethmoidectomy;

- meatal antrostomy;

- Laryngo-tracheal

- removal of vocal cord/fold nodules, polyps and cysts;

- arytenoidectomy;

- tracheal stenosis;

Oropharyngeal

- uvulopalatoplasty (LAUP, laser UPPP);

- tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil;

- hemi glossectomy;

Head & Neck

- tumor resection on oral, subfacial and neck tissues;

- parathyroidectomy;

- thyroidectomy.

Laser Assisted Lipolysis (980 nm only)

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K082721: Laserpro 810, 940 and 980 Diode Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082721

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026