510(k) · Cleared
Recalled · Class II · 2013Laserpro 810, 940 and 980 Diode Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- 2 generations backK080567 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
- 1 generation backK081416 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
- This deviceK082721 Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK151890 Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK252063 Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser…Wuhan Dimed Laser Technology Co., Ltd. · 2025
- 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
- Descendant · 2 generations on · 0 of its ownK191349 980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK173067 LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC · 2018
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
- 3 generations backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- 2 generations backK080567 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
- 1 generation backK081416 Palomar Aspire Laser PlatformPalomar Medical Products, Inc. · 2008
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K053616 | Polaris WR, ST Applicator | Syneron Medical, Ltd. | 2006 | — |
| −3 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| −2 | K080567 | Palomar Aspire Laser Platform | Palomar Medical Products, Inc. | 2008 | — |
| −1 | K081416 | Palomar Aspire Laser Platform | Palomar Medical Products, Inc. | 2008 | — |
| 0 (this device) | K082721 | Laserpro 810, 940 and 980 Diode Laser Systems | Photo Medex, Inc. | 2008 | — |
| +1 | K151890 | Medical Diode Laser Systems | Wuhan Gigaa Optronics Technology Co., Ltd. | 2015 | — |
| +2 | K252063 | Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems… | Wuhan Dimed Laser Technology Co., Ltd. | 2025 | — |
| +1 | K243141 | Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810)… | Jiangxi Medex Technology Co., Ltd. | 2024 | — |
| +2 | K191349 | 980nm Diode Laser Therapy Device | Shanghai Apolo Medical Technology Co., Ltd. | 2019 | — |
| +2 | K173067 | LightForce LTS Model 1000, 1500, 2500, and 4000 | Litecure, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 18 | 0 |
| 1995 | 16 | 0 |
| 1996 | 24 | 0 |
| 1997 | 27 | 0 |
| 1998 | 25 | 0 |
| 1999 | 22 | 0 |
| 2000 | 31 | 0 |
| 2001 | 29 | 0 |
| 2002 | 36 | 0 |
| 2003 | 32 | 0 |
| 2004 | 19 | 0 |
| 2005 | 12 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSummary 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… | 2004 |
| * | K040294 | Laserpro Diode Laser Systems, Models 810, 940 & 980Summary 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… | 2004 |
| * | K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25Summary 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… | 2008 |
| * | K001975 | Ceralas D10 810NM Laser, Model Ceralas D10-60Summary 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 *… | 2000 |
| * | K062363 | BWF-5 Medical Laser Series, 810 NM; 930 NM; 980 NM; 1080 NMSummary 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… | 2007 |
| * | K954316 | Aurora Surgical Diode Laser System W/AccessoriesSummary 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 ·… | 1995 |
| * | K952661 | SLT Thermalite Diode Laser Series, Diode 980, 810, 940Summary 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… | 1995 |
| * | K073617 | Pharaon LipoSummary 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… | 2008 |
| * | K080567 | Palomar Aspire Laser PlatformSummary 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… | 2008 |
| * | K081416 | Palomar Aspire Laser PlatformSummary 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… | 2008 |
| * | K062321 | Smartlipo ND:Yag LaserSummary 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… | 2006 |
| * | K072751 | Cooltouch Models NS 160 and LC215 CoolipoSummary 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' ,… | 2008 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2013 | Class II | Z-0005-2014 | Process change control | Firm 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 devicesGEX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
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.
https://510kreport.com/device/K082721 · printed Nov 6, 2026
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