# K192430: Epic 980

- Pathway: 510(k) (Special)
- Applicant: Biolase, Inc.
- Decided: Dec 4, 2019 after 90 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: 18 generations back to K943450 (1995). 229 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 235 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121286: EPIC 10, Biolase Technology, Inc. (2012) Summary page 5.

## Most influential descendants
- K193486: Epic 980 (2020), 2 descendants of its own
- K234085: LUNE™ PureHygiene (2024), 1 descendant of its own
- K261047: Dental Diode Laser Device (Laser-Pen) (2026), 0 descendants of its own
- K260138: LUNE PureHygiene (2026), 0 descendants of its own
- K232222: Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) (2023), 0 descendants of its own

## Indications for use
1. Dental Soft Tissue Indications Incision, excision, vaporization, ablation and coagulation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft-tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa Vestibuloplasty Tissue retraction for impression 2. Laser Periodontal Procedures Laser soft-tissue curettage Laser removal of diseased, infected, inflamed and necrosed soft-tissue within the periodontal pocket Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft-tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) 3. Whitening Light activation for bleaching materials for teeth whitening Laser-assisted whitening/bleaching of teeth 4. Pain Therapy Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Source page: https://510kreport.com/device/K192430
Methodology: https://510kreport.com/methodology