# K083616: Patholase Family of Pinpointe and Pinpointe  Footlaser ND: Yag Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Patholase, Inc.
- Decided: Jun 12, 2009 after 186 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 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

Source page: https://510kreport.com/device/K083616
Methodology: https://510kreport.com/methodology