510(k) · Cleared
ClearedInpulse Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incisive, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jul 18, 2013 as substantially equivalent to K093547 (Pinpointe USA, Inc., 2010) after a 29-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Jul 18, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K936109 (1994). 34 ancestors in all, the oldest K853620 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 7 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 6 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 5 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 4 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 3 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 2 generations backK083215 Incisive Family of Inpulse ND:Yag LasersIncisive, LLC · 2009
- 1 generation backK093547 Pinpointe FootlaserPinpointe USA, Inc. · 2010
- This deviceK131805 Inpulse LaserIncisive, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −7 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −5 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −4 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −3 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −2 | K083215 | Incisive Family of Inpulse ND:Yag Lasers | Incisive, LLC | 2009 | — |
| −1 | K093547 | Pinpointe Footlaser | Pinpointe USA, Inc. | 2010 | — |
| 0 (this device) | K131805 | Inpulse Laser | Incisive, Inc. | 2013 | — |
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 |
| 2009 | 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? (1)
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 |
|---|---|---|---|
| * | K093547 | Pinpointe FootlaserSummary page 1…InPulse Laser Primary Classification Namne(s): Electrosurgical cutting and coagulation device and accessories Ill. Predicate Devices * K093547 - PinPointe FootLaser and Accessories Premarket Notification Special 510(k) Submission SectionS8: Pa… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 34 ancestors has a recall of any class.
- 11 other devices also cite its predicate K093547.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 InPulse LaserTm 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 lENT surgery, and dermatology & plastic surgery including intracral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general…
Read the full statement (385 words)
The InPulse LaserTm 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 lENT surgery, and dermatology & plastic surgery including intracral soft tissue dental surgery, oral maxillo-facial and cosmetic surgery, general surgery, E.N.T. surgery, podiatry, and dermatology and plastic surgery.
Podiatry
Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including:
*Matrixectomy
*Periungual and subungual warts
*Plantar warts
*Radical nail excision
*Neuromas
The InPulse FootLaser is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophylon rubrum and T'. mentagrophytes, and/or yeasts Candida albicans, etc.).
Dermatolojzv 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
*Hemangiomas
*Plantar warts
*Periungual and subungual warts
* Removal of tattoos
* Debridement of decubitus ulcer
*Treatment of keloids
Oroo~harangeal/ Dental Surp-erv Indicated for:
*Abscess incision and drainage
*Aphthous ulcers treatment
*Biopsies, excisional and incisional
*Crown lengthening
*Exposure of unerupted I partially erupted teeth
*Fibromfi removal
* Frenectomy
- Frenotomy
*Gingival incision and excision
*Gingivectomy
*Gingivoplasty
* Hemostasis
* Implant removal
*Lesion (tumor) removal
* Leukoplakia
*Operculectomy
*Oral papillectomy
* Pulpotomy
*Pulpotomy as adjunct to root canal therapy
*Removal of fzllingmnateriall 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 uI;DsLugauabation, vaporization, incision, excision, and coagulation of soft tissue) including:
* Cholecystectomy
Lymphadenectomy
Mastectomy
* Partial nephrectoniy
* Hepatectomy
* Pilonidal cystectomy
Pancreatectomy Resection oflipoma Splenectomy
* Pelvic adhesiolysis
Hemorrhoidectomy
Removal of lesions
Thyroidectomy
Removal of polyps
Parathyroidectomy
Removal oftumors
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131805 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131805: Inpulse Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131805
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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