510(k) · Cleared
ClearedPatholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Patholase, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 12, 2009 as substantially equivalent to K011703 (Lumenis, 2001) and 1 other predicate after a 186-day review. Its family tree reaches back 6 generations to 1994. 136 later devices descend from it.
- Decided
- Jun 12, 2009
- Review
- 186 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K936109 (1994). 31 ancestors in all, the oldest K853620 (1986). 136 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 4 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 3 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 2 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 1 generation backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- This deviceK083616 Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc. · 2009
- Descendant · cites it directly · 122 of its ownK093545 Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010
- Descendant · 2 generations on · 121 of its ownK103626 Cutera Genesisplus Laser SystemCutera, Inc. · 2011
- Descendant · cites it directly · 115 of its ownK093547 Pinpointe FootlaserPinpointe USA, Inc. · 2010
- Descendant · 2 generations on · 65 of its ownK113702 Fotona XP ND: Yag Laser SystemFotona D.D. · 2012
- Descendant · 3 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Showing 5 of 136 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 136 · See all- K093545Pinpointe Footlaser Model 6W, 30W, 100WIncisive, Inc. (Formerly Named Incisive, LLC) · 2010 · cites it directly122descendants
- K103626Cutera Genesisplus Laser SystemCutera, Inc. · 2011 · 2 generations on121descendants
- K093547Pinpointe FootlaserPinpointe USA, Inc. · 2010 · cites it directly115descendants
- K113702Fotona XP ND: Yag Laser SystemFotona D.D. · 2012 · 2 generations on65descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 3 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −5 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −3 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −2 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −1 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| 0 (this device) | K083616 | Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers | Patholase, Inc. | 2009 | — |
| +1 | K093545 | Pinpointe Footlaser Model 6W, 30W, 100W | Incisive, Inc. (Formerly Named Incisive, LLC) | 2010 | — |
| +2 | K103626 | Cutera Genesisplus Laser System | Cutera, Inc. | 2011 | — |
| +1 | K093547 | Pinpointe Footlaser | Pinpointe USA, Inc. | 2010 | — |
| +2 | K113702 | Fotona XP ND: Yag Laser System | Fotona D.D. | 2012 | — |
| +3 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 8 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 10 | 0 |
| 2024 | 14 | 0 |
| 2025 | 19 | 0 |
| 2026 | 13 | 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? (2)
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 |
|---|---|---|---|
| * | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag)… | 2001 |
| * | K011423 | Inpulse Dental LaserSummary page 2…handpiece and fits securely into the bore of the Guide tip; * Delivery Devices for Contact with Breached Surfaces (Previously Cleared in K011423): > Optical. Fibers - Reusable, cleanable, sterilizable optical fibers (range of… | 2001 |
What descends from it? (136)
See all 1362 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)
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 15 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 31 ancestors has a recall of any class.
- Of its descendants, K093545 (Incisive, Inc. (Formerly Named Incisive, LLC), 2010) has gone furthest, with 122 descendants of its own.
- 18 other devices also cite its predicate K011703.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 PathoLase Family of PinPointe TM and PinPointeTM FootLaserTM Nd:YAG Lasers and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including: Oropharangeal / Dental…
Read the full statement (399 words)
The PathoLase Family of PinPointe TM and PinPointeTM FootLaserTM Nd:YAG Lasers and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, excision, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including:
Oropharangeal / Dental Surgery
Indicated for:
* Abscess incision and drainage
* Aphthous ulcers treatment
* Biopsies, excisional and incisional
* Crown lengthening
* Exposure of unerupted / partially erupted teeth
* Fibroma removal
* Frenectomy
* Frenotomy
* Gingival incision and excision
* Gingivectomy
* Gingivoplasty
* Hemostatis
* Implant recovery
* Lesion (tumor) removal
* Leukoplakia
* Operculectomy
* Oral papillectomy
* Pulpotomy
Oropharangeal / Dental Surgery - Continued
* Pulpotomy as adjunct to root canal therapy
* Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment
* Selective ablation of enamel (first degree) caries removal
* Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility
* Tissue retraction for impressions
* Vestibuloplasty
General Surgery
Indicated for:
Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
- Cholecystectomy
- Lymphadenectomy
- Mastectomy
- Partial nephrectomy
- Hepatectomy
- Pilonidal cystectomy
- Pancreatectomy
- Resection of lipoma
- Splenectomy
- Pelvic adhesiolysis
- Hemorrhoidectomy
- Removal of lesions
General Surgery - Continued
- Thyroidectomy
- Removal of polyps
- Parathyroidectomy
- Removal of tumors
- Herniorrhaphy
- Tumor biopsy
- Tonsillectomy
- Debridement of decubitus ulcers
- Appendectomy
Endonasal Surgery
Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
* Lesions or tumors of the oral, nasal, glossal, pharyngeal & laryngeal tissues
* Tonsillectomy
* Adenoidectomy
Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
* Matrixectomy
* Periungual and subungual warts
* Plantar warts
* Radical nail excision
* Neuromas
Dermatology and Plastic Surgery
Dermatology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
* Lesions of skin and subcutaneous tissue
* Telangiectasia
* Port wine lesions
* Spider veins
* Hemangiomnas
* Plantar warts
* Periungual and subungual warts
* Removal of tattoos
* Debridement of decubitus ulcer
* Treatment of keloids
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083616 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083616: Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083616
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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