# K212790: XLase Plus

- Pathway: 510(k) (Traditional)
- Applicant: Biotec Italia, Srl
- Decided: Aug 15, 2022 after 348 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: 23 generations back to K943450 (1995). 550 ancestors in all.
No later device cites it as a predicate yet.
0 of 551 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192539: Deka Luxea, El.En Electronic Engineering Spa (2019) Summary page 6.

## Indications for use
XLase Plus is indicated for use as follows: Diode 808/760 nm 4000W ALEX PRO Handpiece: Indicated for the treatment of hair removal with static and dynamic modes intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. * Treatment of Pseudofolliculitis barbae (PFB) * Use on all skin types (Fitzpatrick I-VI). SLP ND:YAG 1064 nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and benign vascular lesions, treatment of benign pigmented lesions, such as but not limited to warts, telangiectasia, leg veins and spider veins. Q Switch ND:YAG 1064 nm Handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions. CPL Handpiece: Indicated for use Fitzpatrick skin types I — IV, as shown in the table below. Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Photocoagulation of benign vascular lesions, photo thermolysis of blood vessels, treatment of benign pigmented lesions. Pulsed light Hair reduction Benign Blood vessels Benign Wavelength range Vascular lesions Pigmented lesions 500-1200nm - Skin Types [, 11 Skin Types [, 11 - 520-1200nm - SkinType 111 Skin Type 11 Skin Types I, 11 550-1200nm Skin Types I, 11 - - Skin Type Il 595-1200nm Skin Type I - - - 650-1200nm Skin Type [V - - Skin Type IV ERBIUM:YAG FRACTIONAL 2940 nm Handpiece: Indicated for procedure requiring resurfacing of soft tissue with fractionated handpiece. Diode 2800W 810nm Handpiece: Indicated for use on all skin types (Fitzpatrick skin types I — VI), including tanned skin. Indicated for: - the treatment of benign vascular and benign pigmented lesions, - permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Diode 1200W 810nm Handpiece: Indicated for use on all skin types (Fitzpatrick skin types I — VI), including tanned skin. Indicated for the treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudo folliculitis barbae. Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Indicated for the treatment of benign pigmented lesions and leg veins. ALEX 755nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. Treatment of benign pigmented lesions. Treatment of wrinkles and the photocoagulation of dermatological benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). On all skin types (Fitzpatrick I- VI) including tanned skin.

Source page: https://510kreport.com/device/K212790
Methodology: https://510kreport.com/methodology