# K083215: Incisive Family of Inpulse ND:Yag Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Incisive, LLC
- Decided: Apr 8, 2009 after 159 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K936109 (1994). 31 ancestors in all.
136 later devices descend from it; 2 cite it directly.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001)
- K011423: Inpulse Dental Laser, Incisive, LLC (2001) Summary page 2.

## Most influential descendants
- K093545: Pinpointe Footlaser Model 6W, 30W, 100W (2010), 122 descendants of its own
- K103626: Cutera Genesisplus Laser System (2011), 121 descendants of its own
- K093547: Pinpointe Footlaser (2010), 115 descendants of its own
- K113702: Fotona XP ND: Yag Laser System (2012), 65 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Indications for use
The Incisive Family of InPulse 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: Oropharyngeal / 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 • Hemostasis • Implant recovery • Lesion (tumor) removal • Leukoplakia • Operculectomy • Pulpectomy • Pulpotomy • 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 • Prinephrectomy • Hepatectomy • Pilonidal cystectomy • Pancreatectomy • Pelvic adhesiolysis • Hemorrhoidectomy • Removal of lesions • 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 • Hemangiomas • Plantar warts • Periungual and subungual warts • Removal of tattoos • Debridement of decubitus ulcer • Treatment of keloids

Source page: https://510kreport.com/device/K083215
Methodology: https://510kreport.com/methodology