# K053421: Yag  Mir Family Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Feb 1, 2006 after 55 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Cynosure YAG Family laser: named in the summary without a submission number

## Indications for use
1064rim: The Cynosure YAG MIR Family laser is intended for the coagulation and hemostasis of benign vascular lesions, such as , but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, stiae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Cafd au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent, hair reduction through selective targeting of melanin in the hair follicles, and for the treatment of pseudofolliculitis barbae (PFB). 1440nm: The Cynosure YAG MIR Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles and pigmented lesions.

Source page: https://510kreport.com/device/K053421
Methodology: https://510kreport.com/methodology