510(k) Report

510(k) · Cleared

Cleared

Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene

K053540510(k) TraditionalCleared Sep 6, 2006260-day reviewClass II21 CFR 878.4810

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

Intermedic Arfran, SA · GEX Powered Laser Surgical Instrument

Cleared on Sep 6, 2006 as substantially equivalent to K042211 (Surgical Laser Technologies, Inc., 2004) and 14 other predicates after a 260-day review. Its family tree reaches back 13 generations to 1995. 299 later devices descend from it.

Decided
Sep 6, 2006
Review
260 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
15

Its longest line of descent runs back 13 generations to K943450 (1995). 160 ancestors in all, the oldest K800617 (1980). 299 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 4 other ancestors2004: 6 other ancestors2003: 12 other ancestors2002: 17 other ancestors2001: 11 other ancestors2000: 13 other ancestors1998: 9 other ancestors1997: 18 other ancestors1995: 12 other ancestors1999: 6 other ancestors1996: 14 other ancestors1993: 6 other ancestors1994: 9 other ancestors1990: 1 other ancestor1989: 1 other ancestor1985: 1 other ancestor1980: 1 other ancestor1992: 3 other ancestors1991: 3 other ancestors2010: 9 descendants cleared2007: 4 descendants cleared2008: 6 descendants cleared2009: 7 descendants cleared2012: 7 descendants cleared2011: 5 descendants cleared2013: 12 descendants cleared2022: 25 descendants cleared2020: 20 descendants cleared2021: 12 descendants cleared2023: 17 descendants cleared2014: 11 descendants cleared2015: 13 descendants cleared2016: 11 descendants cleared2024: 30 descendants cleared2026: 24 descendants cleared2018: 15 descendants cleared2019: 13 descendants cleared2017: 12 descendants cleared2025: 46 descendants 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. · 2003K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 14 other ancestors3 generations back: 28 other ancestors4 generations back: 33 other ancestors5 generations back: 23 other ancestors6 generations back: 30 other ancestors7 generations back: 3 other ancestors8 generations back: 2 other ancestors 1 generation forward: 8 descendants2 generations forward: 17 descendants3 generations forward: 47 descendants4 generations forward: 66 descendants5 generations forward: 72 descendants6 generations forward: 59 descendants7 generations forward: 26 descendants8 generations forward: 4 descendants K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K031671 · 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. · 1995−10−50+5
  1. Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 9 generations between
  3. 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  4. 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  5. 1 generation backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  6. This deviceK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  7. Descendant · cites it directly · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
  8. Descendant · cites it directly · 230 of its ownK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  9. Descendant · cites it directly · 229 of its ownK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  10. Descendant · cites it directly · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
  11. Descendant · 2 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
Show all 13 generations
  1. Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 9 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 8 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 7 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 6 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 5 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 4 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 1 generation backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. This deviceK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006

Showing 5 of 299 descendants. See all descendants

Descendants cleared per year

2007: 42008: 62009: 72010: 92011: 52012: 72013: 122014: 112015: 132016: 112017: 122018: 152019: 132020: 202021: 122022: 252023: 172024: 302025: 462026: 24
2007high 46 (2025) · low 4 (2007)2026

Most influential descendants

Showing 5 of 299 · See all
  • K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · cites it directly263descendants
  • K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · cites it directly230descendants
  • K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007 · cites it directly229descendants
  • K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · cites it directly192descendants
  • K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 2 generations on177descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−12K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−11K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−10K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−9K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−8K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−7K000944Thermage Thermacool SystemThermage, Inc.2000—
−6K013034Modification to: Thermacool IiaThermage, Inc.2001—
−5K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−4K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−3K030142Thermacool TC SystemThermage, Inc.2003—
−2K031671Polaris WRSyneron Medical, Ltd.2003—
−1K041959Polaris DS/CometSyneron Medical, Ltd.2004—
0 (this device)K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
+1K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007—
+1K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
+1K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
+1K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008—
+2K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
198910
199010
199130
199230
199360
199490
1995120
1996140
1997180
199890
199960
2000130
2001110
2002170
2003120
200460
200540

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200740
200860
200970
201090
201150
201270
2013120
2014110
2015130
2016110
2017120
2018150
2019130
2020200
2021120
2022250
2023170
2024300
2025460
2026240
FIG. 1 — Lineage of K053540, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (15)

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 7
…Panel: 79 Class: II Predicate Device PhotoMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K0419…
Surgical Laser Technologies, Inc.2004—
*K040294Laserpro Diode Laser Systems, Models 810, 940 & 980
Summary page 7
…nel: 79 Class: II Predicate Device PhotoMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K0507…
Photo Medex, Inc.2004—
*K031993Aurora SR
Summary page 7
…PhotoMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K0508…
Syneron Medical, Ltd.2003—
*K050452Aurora SR and Sra Applicator
Summary page 7
…PhotoMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824)…
Syneron Medical, Ltd.2005—
*K052324Polaris LV, Lva Applicator
Summary page 7
…toMedex Laser Pro 810, 940 and 980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824)…
Syneron Medical, Ltd.2005—
*K041969Aurora DS
Summary page 7
…980 Diode Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Las…
Syneron Medical, Ltd.2004—
*K041959Polaris DS/Comet
Summary page 7
…Laser Systems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System…
Syneron Medical, Ltd.2004—
*K050796Aurora DS, DS Applicator
Summary page 7
…stems (K042211, K040294) Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System (K032864…
Syneron Medical, Ltd.2005—
*K050824100W Ceralas D 980 Laser System, Model D100
Summary page 7
…Syneron Lasers, Aurora & Polaris (K031993, K050452, K052324, K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296)…
Biolitec, Inc.2005—
*K032864Ceralas D 810 Diode Laser System, Model D15
Summary page 7
…K041969, K041959, K050796) Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K00…
Biolitec, Inc.2004—
*K002296Ceralas G15 532NM Frequency Doubled ND:Yag Laser, Model G1-G15
Summary page 7
…Ceralas D 980 Diode Laser System (K050824) Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Sub…
Ceram Optec, Inc.2000—
*K021724Dornier Diode Laser Family, Including Medilas D Fibertom, Medilas D Skinpulse & Medilas…
Summary page 7
…Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Substantial Equivalence The INTERmedic Di…
Dornier Medtech America, Inc.2002—
*K000072Dornier Medilas D Skinpulse
Summary page 7
…Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Substantial Equivalence The INTERmedic Diode Laser…
Dornier Surgical Products, Inc.2000—
*K003993Dornier Medilas D Skinpulse Laser System (Skinpulse)
Summary page 7
…Ceralas D 810 Diode Laser System (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Substantial Equivalence The INTERmedic Diode Laser Family i…
Dornier Surgical Products, Inc.2001—
*K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…
Summary page 7
…tem (K032864) Ceralas G Laser System (K002296) Dornier's Diode Laser Family (K021724, K000072, K003993, K020339) Rationale for Substantial Equivalence The INTERmedic Diode Laser Family including Accessories have…
Dornier Medtech America, Inc.2002—

Also cleared against K042211: 2 other devices →

What descends from it? (299)

See all 299

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

NumberDeviceApplicantDecidedDescendants
K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263
K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230
K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229
K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192
K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054
K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722
K093087BWF-5 Medical Laser SeriesLitecure, LLC20100
K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 9 months on median.
  • 6 of the 160 ancestors have a recall of any class.
  • Of its descendants, K072034 (Quanta System Spa, 2007) has gone furthest, with 263 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.

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 INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including…

Read the full statement (512 words)

The INTERmedic Diode Laser Family (and their delivery accessories used to deliver optical, ultrasound and RF energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialties including: Urology, Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/Neck/ENT and Radiology, Endovascular coagulation, Oral Surgery and Dental procedures.

Examples include:

» LASER 810nm and 980nm

Urology:

• Lesions of external genitalia

• Circumcision

• Condyloma

• Bladder tumors

• Bladder neck incisions

• Vaporization of the prostate

• Hepatobiliary tumors

General Surgery:

• Rectal an anal hemorrhoidectomy

• Mastectomy

• Dermabrasion

• Appendectomy (open and laparoscopic)

• Bowel resection (open and laparoscopic)

• Colectomy

• Liver resection

• Resections of organs

• Thyriodectomy

• Adhesiolysis

• Thoracotomy

• Cholecystectomy (open and laparoscopic)

• Condyloma

• Breast biopsy

Neurosurgery:

• Percutaneous Disc Decompression

• Discectomy

• Hemostasis in conjunction with meningiomas

Gynecology:

• Cervical conization

• Myomectomy

• Endometrial ablation

• Ovarian cystectomy

• Appendectomy

Ophthalmology:

• Dacryocystorhinostomy transcanalicular

• Open DCR

• Tumor excision

• Blepharoplasty

Orthopedics:

• Dissect and coagulate

Gastroenterology:

• Hemostasis of colonoscopy

• Hemostasis of esophageal varices

• Excision of polyps

Arthroscopy:

• Chondromalacia

• Synovectomy

• Menisectomy

Thoracic Surgery:

• Thoracotomy

• Pulmonary resection

• Hemostasis

• Pericardiectomy

• Adhesiolysis

• Coagulation of blebs and bullae

Pulmonology:

• Endoscopic pulmonary applications

• Tracheal bronchial lesions

• Benign an malignant pulmonary obstruction

Otolaryngology ENT:

• Removal of benign lesions from the ear, nose and throat

• Excision of carcinoma of the larynx

• Incision and excision of carcinoma in situ

• Neck dissection

• Laryngeal papillomectomy

• Removal of vocal cord/fold nodules, polyps and cysts

Dental applications:

• Frenectomy

• Frenotomy

• Biopsy

• Pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening

Pulmonary Surgery:

• Endoscopic pulmonary applications

• Tracheal bronchial lesions

• Benign and malignant pulmonary or stricture

Cardiac Surgery:

• Coagulation and hemostasis of cardiac tissue

Dermatology/Aesthetics:

• Photocoagulation of vascular & dermatological lesions of the face and extremities

• Photocoagulation of telangiectasia, veinulectasias of the legs and face

• Treatment of reticular veins and branch varicosities

• Pyogenic granuloma, lymphangioma and lymphagiomatosis disease, angiofibromas.

• Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.

Dermatological surgery:

Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasy and ulcers debridment.

Seborrheic keratosis

Mixoid cyst

Papillary varix

Acne treatment

Hair removal of unwanted hair from skin type I-V

Plastic Surgery:

• Cut, coagulation & vaporization

• Resurfacing non

• Blepharoplasty

Vascular Surgery:

• Endoluminal or endovenous laser surgery for saphenous incompetent veins

» ContrAge RF

Dermatology/Aesthetics:

Non invasive treatment of wrinkles and rhytids

Non invasive scar reduction treatment (acne or traumatic scars)

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K053540: Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053540

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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