# K113115: Epicare Yag

- Pathway: 510(k) (Traditional)
- Applicant: Light Age, Inc.
- Decided: Apr 3, 2012 after 165 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: 10 generations back to K910422 (1992). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091625: Epicare-Duo Laser System, Light Age, Inc. (2009) Summary page 1.
- K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 1.

## Indications for use
The Light Age Inc. EpiCare-YAG Tm Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for the removal of dark tattoo inks and reduction of hypertrophic and keloid scars and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime on all skin types (Fitzpatrick 1-VI including tanned skin.) Specifically the 1064 nm wavelength is indicated for: * Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick I-VI including tanned skin. * Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins, and spider veins and poikiloderma of civatte. Coagulation and hemostasis of soft tissue. * Benign cutaneous lesions such as warts, scars, striae, and psoriasis * Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafd au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. * Pigmented lesion size reduction in patients with lesions who would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. * Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar * Treatment of pseudofolliculitis barbae (PFB). * Treatment of wrinkles including but not limited to periocular wrinkles and perioral wrinkles.

Source page: https://510kreport.com/device/K113115
Methodology: https://510kreport.com/methodology