# K011960: Lares Research Sunlase 800P Laser System (to BE Sold as Pocketpro or Pocketpro S4)

- Pathway: 510(k) (Traditional)
- Applicant: Lares Research, Inc.
- Decided: Dec 21, 2001 after 182 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) American Dental Technologies - PulseMaster™: named in the summary without a submission number
- (no number) American Dental Technologies - DioLase ST™: named in the summary without a submission number
- (no number) BioLase Technology, Inc. - TwiLite™: named in the summary without a submission number
- (no number) CeramOptec - Ceralas® D15: named in the summary without a submission number
- (no number) Dentek Laser Systems - LD-15™: named in the summary without a submission number
- (no number) OpusDent, Ltd. - Opus 10™: named in the summary without a submission number
- (no number) Premier Laser Systems - Aurora™: named in the summary without a submission number
- (no number) Xintec Corporation - Dentica™: named in the summary without a submission number

## Most influential descendants
- K182930: PerioLase Nd:YAG Pulsed Dental Laser System (2019), 0 descendants of its own

## Indications for use
The SunLase 800P laser device is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The device is indicated for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact, fiber-optic delivery system. The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, dermatology and plastic surgery. The following are the oropharangeal indications for use for which the device will be marketed: - Excisional and incisional biopsies - Excision and vaporization of herpes simplex | and || - Exposure of unerupted teeth « Fibroma removal « Frenectomy and Frenotomy « Gingival troughing for crown impressions « Gingivectomy « Gingivoplasty - Gingival incision and excision « Hemostasis + Implant recovery « Incision and drainage of abscess . Laser Assisted Uvulopaletoplasty (LAUP) This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chronic palatal snoring. « Leukoplakia « Operculectomy « Oral Papillectomies « Pulpotomy and Pulpotomy as an adjunct to root canal therapy - Reduction of denture hyperplasia - Reduction of gingival hypertrophy . Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy - Removal of post-surgical granulations . Selective ablation of enamel (First Degree Caries Removal) « Soft tissue crown lengthening « Sulcular debridement or soft tissue curettage (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 impression « Treatment of Apthous ulcers « Vestibuloplasty

Source page: https://510kreport.com/device/K011960
Methodology: https://510kreport.com/methodology