# K153229: Superbium

- Pathway: 510(k) (Traditional)
- Applicant: Bios S.R.L.
- Decided: Apr 12, 2016 after 158 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 K910422 (1992). 359 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 362 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072344: Apl Medical System, Bios S.R.L. (2007) Summary page 7.
- K103664: Primus Aesthetic Platform, Palomar Medical Technologies, Inc. (2011) Summary page 7.
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 7.
- K150140: MCL 31 Dermablate, Asclepion Laser Technologies GmbH (2015) Summary page 7.
- K111303: Dermatological Treatment Device Family, Sharplight Technologies, Ltd. (2011) Summary page 7.
- K090195: Palomar LUX1540 Handpiece, Palomar Medical Technologies, Inc. (2009) Summary page 7.

## Most influential descendants
- K252561: BTL-754FF (2026), 0 descendants of its own
- K163196: ACTION II Laser System (2017), 0 descendants of its own

## Indications for use
The Nd:Yag 1064 Laser Handpiece (Long Pulsed) is intended for: -treatment of benign vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, venus lake, facial and leg veins; -treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, chloasma, cafe-au-lait macules, and plaques; -tattoos (significant reduction in the intensity of black and/or blue-black tattoos); verrucae, skin tags, seborrheic keratosis; - reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar; - coagulation and hemostasis of soft tissue; -the removal of unwanted hair for skin types I-VI, and to effect stable long-term permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The Nd:Yag 1064 Laser Handpiece (Short Pulsed) is intended for: Removal of tattoos and blemishes of the skin, the treatment of various pigmentation lesions Laser skin treatment procedures for the treatment of: Acne scars, Wrinkles The Nd:YAG Q-Switched Handpieces (1064 nm) are indicated for treatment of: - 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; The removal of black, blue or green tattoos (significant reduction in the intensity of black and /or blue/black tattoos); Plaques - Pigmented benign 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), including tanned skin. The Nd:YAG Q-Switched Handpieces (532 nm) are indicated for treatment of: -Incision, excision, ablation, vaporization of soft tissue. - 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: Cafe-au-lait (macules); Lentigines (senile and solar); Freckles (ephelides); Chloasma; Nevi; Nevus spillus; Nevus of Ota ;Becker's Nevi -Other benign pigmented cutaneous lesions: Verrucae; Skin tags; Keratoses; Plaques The 2940 nm Er:YAG Laser Module handpiece is indicated for: Coagulation, vaporization, ablation or cutting of soft tissue (skin) in Dermatology, Plastic Surgery, Oral Surgery, ENT, Gynecology, General Surgery, Podiatry and Ophthalmology (skin around the eyes). Laser skin resurfacing procedures for the treatment of: • Acne scars • Wrinkles The 2940 nm Er:Yag Fractional tips are 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 resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars). The 1540 Fractional Non-ablative Laser Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures as well as treatment of melasma, striae, acne scars and surgical scars. IPL 400-1200 run handpiece is indicated for: • The treatment of moderate inflammatory acne vulgaris. • The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). • The treatment of benign cutaneous lesions including warts, scars and striae. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. •Use on all skin types (Fitzpatrick I-VI). IPL500-1200 nm handpiece is indicated for: • The treatment of moderate inflammatory acne (acne vulgaris). • The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars, striae, dyschromia, hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, melasma, and cafe..au-lait macules. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. •Use on Fitzpatrick skin types I-V. IPL 550-1200 nm handpiece is indicated for: • The treatment of moderate inflammatory acne Vulgans. • The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). • The treatment of face and body vascular and pigmented lesions. • The treatment of cutaneous lesions, including scars and striae. • The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Use on all skin types (Fitzpatrick I-VI). IPL 580-1200 run handpiece is indicated for: • The treatment of moderate inflammatory acne vulgaris. • The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles). • The treatment of face and body vascular and pigmented lesions. • The treatment of cutaneous lesions, including scars and striae. • The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Use on all skin types (Fitzpatrick I-VI). IPL 620-1200 nm handpiece is indicated for: • The treatment of tattoos. • The treatment of moderate inflammatory acne vulgaris. • The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles), lentigines, nevi, melasma, and cafe-au-lait. • The treatment of cutaneous lesions including warts, scars and striae. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. : The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. • Use on all skin types (Fitzpatrick I-VI), including tanned skin. IPL 755-1200 nm handpiece is indicated for: • The treatment of tattoos. • The treatment of moderate inflammatory acne vulgaris. • The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). • The treatment of cutaneous lesions including warts, scars and striae. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • The treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis. • The treatment of pseudofolliculitis barbae (PFB). • The removal of unwanted hair to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. •Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Source page: https://510kreport.com/device/K153229
Methodology: https://510kreport.com/methodology