# K121286: EPIC 10

- Pathway: 510(k) (Special)
- Applicant: Biolase Technology, Inc.
- Decided: Sep 28, 2012 after 151 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: 17 generations back to K943450 (1995). 228 ancestors in all.
31 later devices descend from it; 4 cite it directly.
0 of 260 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083069: Ezlase 10W, Biolase Technology, Inc. (2008) Summary page 1.
- K083595: Ezlase, Biolase Technology, Inc. (2009) Summary page 1.
- K061898: Ezlase, Biolase Technology, Inc. (2007) Summary page 1.
- K082938: Ezlase, Biolase Technology, Inc. (2008) Summary page 1.
- K093852: Ezlase 3 Laser System, Biolase Technology, Inc. (2010) Summary page 1.

## Most influential descendants
- K170500: SIROLaser Advance+ (2017), 21 descendants of its own
- K180044: SIROLaser Blue (2018), 12 descendants of its own
- K193656: SkyPulse (2020), 11 descendants of its own
- K210367: D-Laser Blue, D-Laser 16 (2022), 6 descendants of its own
- K192430: Epic 980 (2019), 5 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 refraction 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 ahd 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. Witening Light activation for bleaching materials for teeth whitenifivisiof SignlOfl) 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 stiffniess, 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/K121286
Methodology: https://510kreport.com/methodology