# K091625: Epicare-Duo Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Light Age, Inc.
- Decided: Nov 3, 2009 after 153 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 K910422 (1992). 68 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032991: Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPX, Light Age, Inc. (2004) Summary page 1.
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 1.
- K063074: Candela 3630 Laser System, Candela Corp. (2006) Summary page 1.

## Most influential descendants
- K113115: Epicare Yag (2012), 0 descendants of its own

## Indications for use
The Light Age, Inc. EpiCare-DUOTM Laser System is intended for use in general and plastic surgery, dermatology, and podiatry for the treatment of vascular lesions, benign pigmented lesions, for 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 I-VI including tanned skin.) No new indications were sought in this 510(K) and no clinical data is presented. Light Age, Inc. is providing more specialized indications which are a subset of the previously cleared indications. From both a design and clinical perspective, the predicate and candidate laser devices, are of the same technology and have the same intended use. Based upon an analysis of the overall performance characteristics for the devices, Light Age, Inc. believes that no significant differences exist. 755nm- Specifically the 755 nm mode is indicated · Hair removal, and stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles on all skin types (Fitzpatrick I-VI) including tanned skin. Permanent hair reduction is defined as long-term stable reduction in the number of hair regrowth after a treatment regime. The number of hairs re- growing must be stable over a time greater than the duration of the complete growth cycle of hair follicles, which varies from 4-12 months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area. * Treatment of vascular lesions * Treatment of benign pigmented lesions. * Treatment of wrinkles. 1064nm - * Removal of unwanted hair, for stable long term or permanent hair reduction on all skin types Fitzpatrick W-VI including tanned skin. • Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemoangioma, 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 striac and psoriasis. * Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), caf6 au lait macules, seborrheio 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 periocular wrinkles and perioral wrinkles.

Source page: https://510kreport.com/device/K091625
Methodology: https://510kreport.com/methodology