# K233304: Omnimax S3, Omnimax S4 - Pathway: 510(k) (Traditional) - Applicant: Sharplight Technologies, Ltd. - Decided: Dec 22, 2023 after 84 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: 17 generations back to K943450 (1995). 257 ancestors in all. No later device cites it as a predicate yet. 0 of 258 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K111303: Dermatological Treatment Device Family, Sharplight Technologies, Ltd. (2011) Summary page 6. - K111026: Apollo, Pollogen, Ltd. (2011) Summary page 6. ## Indications for use The Omnimax Device Series along with its optional Handpieces, uses IPL, IR, Laser and RF technologies and is intended for use in aesthetic and cosmetic applications and in selective treatments in medical specialties of dermatology, through the transmission of energy to human skin. Intense Pulsed Light (IPL-DPC) with 415 – 1200 nm wavelengths (with and without contact-cooling) handpieces are indicated for: * Hair removal and Permanent Hair Reduction in all skin types (I-V) to the Fitzpatrick scale - Recommended wavelengths in the range of 635-950 nm, 730-950 nm or 580-950 nm. * Flow Mode is suitable for Fitzpatrick skin types I-VI. Recommended wavelength: 635nm-950nm. * 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 580-950 nm. * Treatment of Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick scale – Recommended wavelength in the range of 535-950 nm. * 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 & 860-1200nm. * Treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale – Recommended wavelength in the range of 415-950 nm. Infrared (IR) with 850 – 1750 nm wavelengths (with contact cooling) handpieces is indicated for: * Dermatologic Treatment such as, but not limited to: photocoagulation of soft tissue (Scars, Wrinkles, Rhytids and Periorbital Wrinkles). Radio Frequency (RF) handpieces are indicated for: * Treatment of mild to moderate facial wrinkles and rhytids for all skin types. Nd:YAG Laser 1064 nm Long Pulse (LP) handpiece 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. * Treatment of pseudofolliculitis barbae (PFB). * 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: Warts; 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, Chloasma; Verrucae; Skin tags; Keratoses; 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. * 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 I-VI). Nd:YAG 1064 nm Q-Switched Laser with optional 532 nm Frequency Doubler (FD) handpiece indicated for: * The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); * Tattoo removal: Light blue; Yellow; Red; Green. * 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. Er:YAG Laser 2940 nm Long Pulse (LP), with standard and scanner accessory tips handpiece is indicated for: * Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue) for Skin resurfacing; 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/K233304 Methodology: https://510kreport.com/methodology