# K082876: Beamax/ Formax Pulsed Light Device Family

- Pathway: 510(k) (Traditional)
- Applicant: Sharplight Technologies, Ltd.
- Decided: Nov 10, 2008 after 42 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: 15 generations back to K943450 (1995). 241 ancestors in all.
57 later devices descend from it; 1 cites it directly.
0 of 299 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050047: Cutera Optional Pulsed Light Hand Piece Family, Cutera, Inc. (2005) Summary page 1.
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 1.
- K063249: Beamax, Medic Sharplight, Ltd. (2007) Summary page 1.

## Most influential descendants
- K111303: Dermatological Treatment Device Family (2011), 56 descendants of its own
- K133837: Viora V-Total (2014), 33 descendants of its own
- K142093: V20 System (2014), 32 descendants of its own
- K150035: V10 system (2015), 31 descendants of its own
- K153568: InMode Plus System (2016), 18 descendants of its own

## Indications for use
The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology. The BEAMAX/ FORMAX Pulsed Light Device Family and optional Handpies family with 415 - 950 nm wavelengths (with and without contact-cooling) are indicated for: * Hair removal in all skin types (I-VI) to the Fitzpatrick scale. Permanent Hair Reduction. - Recommended wavelengths in the range of 635-950 nm or 580-950 nm * Treatment of Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm * Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 nm * Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm

Source page: https://510kreport.com/device/K082876
Methodology: https://510kreport.com/methodology