# K050047: Cutera Optional Pulsed Light Hand Piece Family

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Mar 31, 2005 after 80 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: 8 generations back to K910422 (1992). 66 ancestors in all.
109 later devices descend from it; 5 cite it directly.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033549: Starlux Pulsed Light System, Palomar Medical Products, Inc. (2004) Summary page 1.
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004) Summary page 1.
- K020941: Palomar Luxg Handpiece, Palomar (2002) Summary page 1.
- K032460: Profile BBL System, Sciton, Inc (2003) Summary page 1.
- (no number) PRIMA Pulsed Light Therapy System manufactured by CoolTouch: named in the summary without a submission number

## Most influential descendants
- K082876: Beamax/ Formax Pulsed Light Device Family (2008), 57 descendants of its own
- K111303: Dermatological Treatment Device Family (2011), 56 descendants of its own
- K060407: Juniper Cooling Device (2006), 36 descendants of its own
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own

## Indications for use
The Cutera Optional Pulsed Light Hand Piece Family is indicated for use in the surgical, aesthetic and cosmetic applications requiring selective photothermolysis in the medical specialties of general and plastic surgery and dermatology. The Cutera Optional Pulsed Light Hand Piece Family is intended for the treatment of: * Tattoos; * Benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); * Cutaneous lesions including warts, scars and striae; * Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, roasacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; * Psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; * Removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and * Mild to moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K050047
Methodology: https://510kreport.com/methodology