# K111303: Dermatological Treatment Device Family - Pathway: 510(k) (Traditional) - Applicant: Sharplight Technologies, Ltd. - Decided: Dec 21, 2011 after 226 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: 16 generations back to K943450 (1995). 251 ancestors in all. 56 later devices descend from it; 7 cite it directly. 0 of 308 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K082876: Beamax/ Formax Pulsed Light Device Family, Sharplight Technologies, Ltd. (2008) Summary page 1. - K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 1. - K050047: Cutera Optional Pulsed Light Hand Piece Family, Cutera, Inc. (2005) Summary page 1. - K060069: Palomar Luxir Fractional Handpiece, Palomar Medical Technologies, Inc. (2006) Summary page 1. ## Most influential descendants - 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 - K172302: InMode PLUS System (2017), 13 descendants of its own ## Indications for use The Dermatological Treatment Systems device family and optional Hand Piece family are intended for use in aesthetic and cosmetic applications and in selective treatments required in the medical specialties of dermatology. The Dermatological Treatment device family and optional Hand pieces with 415 - 1200 nin wavelengths (with and without contact-cooling) are indicated for: * Hair removal and Permanent Hair Reduction in all skin types (I-VT) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950rn * Treatment of Pigmented and Vascular Lesions in all skin types (L-VI) to the Fitzpatrick scale - Recommended wavelength in the range of 535-950 n * Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 415-950 nm * Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (1-VT) to the Fitzpatrick scale - Recommended wavelength in the range of 580-950 nmn *Treatment of Benign Pigmented Epidermal, Cutaneous and Vascular Lesions including warts; scars and striae in skin types (I-V) to the Fitzpatrick scale - Recommended wavelength in the range of 535-680 nm & 860-l200nm The Dermatological Treatment device family and optional Infrared (IR) Hand Pieces with 850 - 1750 nm wavelengths (with contact cooling) is indicated for: *Dermnatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles) The Dermatological Treatment device family and optional Nd:YAG Laser 1064 nm Long Pulse (LP) Hand Pieces is indicated for: " Removal of unwanted hair, for stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles. " Removal or lightening of unwanted hair (with and without adjuvant preparation) " Treatment of pseudofolliculitis barbae (PEB) The Dermatological Treatment device family and optional Nd:YAG Laser 1064 unm Long Pulse (LP) and Q-Switched Hand Pieces is indicated for: " Benign vascular lesions such as. but not limited to treatment of:- Port wine stains; Hemangiomas; Warts, Superficial and deep telangiectasias (venulectasias); Reticular veins (0.1-4.0 mm dia.) of the leg; Rosacea; Venus lake; Leg veins; Spider veins; Poikiloderma of Civatte; Angiomas " Benign cutaneous lesions, such as. but not limited to: Wadts; Scars; Striae; Psoriasis " Benign pigmented lesions such as. but not limited to: Lentigos (age spots); Solar lentigos (sun spots); Cafe-au-lait macules; Seborrheic; keratoses; Nevi and nevus of Ota, Chlcasma; Verrucae; Skin tags; Keratoses; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques " Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment and for patients with lesions that have not responded to other laser treatments. " The non-ablative treatment of facial wrinkles, such as. but not limited to: Periocular wrinkles; Perioral wrinkles Continued : The Dermatological Treatment device family and optional Nd:YAG Laser 1064 nm Long Pulse (LP) and Q-Switched Hand Pieces is indicated for: * Laser skin resurfacing procedures for the treatment of: Acne scars; Wrinkles * Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. * Indicated for use on all skin types (Fitzpatrick 1-VI), including tanned skin. The Dermatological Treatment device family and optional Nd:YAG Laser 532 nm Frequency Dabbler (FD) Long Pulse (LP) and Q-Switched Hand Pieces is indicated fo r: " Tattoo removal: Light blue; Yellow; Red; Green " Vascular lesions: Hemangiomas (Port wine stains/birthmarks, cavernous, cherry, spider); hemangiomas; Angiomas (cherry, spider); Telangiectasia; Spider nevi * Benign pigmented lesions, such as. but not limited to: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus, Nevus of Ota; Becker's Nevi; " Other pigmented cutaneous lesions, such as. but not limited to: Verrucae; Skin tags; Keratoses; Plaques The Dermatological Treatment device family and optional Er:VAG Laser 2940 nm Long Pulse (LP) Hand Pieces, with standard and scanner accessory tips is indicated for: Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: *Dermatology and plastic Surgery: Skin resurfacing3 Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars); Source page: https://510kreport.com/device/K111303 Methodology: https://510kreport.com/methodology