# K123004: Mira Lasers

- Pathway: 510(k) (Traditional)
- Applicant: Mira Lasers, LLC
- Decided: Jan 15, 2013 after 110 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: 9 generations back to K922901 (1992). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113212: Dental Laser Therapy System, China Daheng Group, Inc. (2011) Summary page 2.
- K083142: Picasso Laser System, Amd Lasers, LLC (2009) Summary page 2.

## Indications for use
The MIRA LASERS is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications: - Excision and Incision Biopsies - Hemostatic assistance - Treatment of Apthous Ulcers - Frenectomy - Frenotomy - Gingival Incision and Excision - Gingivectomy - Gingivoplasty - Incising and Draining of Abscesses - Operculectomy - Oral Papillectomy - Removal of Fibromas - Soft Tissue Crown Lengthening - Sulcular Debridement (removal of diseased or inflamned soft tissutein the periodontal pocket) - Tissue retraction for Impression - Vestibuloplasty - Laser assisted whitening/bleaching of teeth - Light activation for bleaching materials for teeth whitening

Source page: https://510kreport.com/device/K123004
Methodology: https://510kreport.com/methodology