Manufacturer
Biotec Italia, SrlXLase Plus
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K212790
- Device name
- XLase Plus
- Company
- Biotec Italia, Srl
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-09-01
- Decision date
- 2022-08-15
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
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, photothermolysis of blood vessels, treatment of benign pigmented lesions. 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, telangiectasia
Intended 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, photothermolysis of blood vessels, treatment of benign pigmented lesions. 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. ALEX 755nm Handpiece: Indicated for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of
Device Description
XLase Plus, laser for medical applications. It features two models: XLase Plus Standing (with wheels) and XLase Plus Table (tabletop). The two medical devices are identical, contain the same electronic boards and the same critical components, use the same software and are able to perform the same aesthetic treatments. The generic components of XLase Plus Table are a subset of those of XLase Plus Standing. The difference between the two devices is that XLase Plus Standing is built on wheels while XLase Plus Table has no wheels but can be easily placed on a table due to its low weight. The device is for prescription use only. The XLase Plus Standing and XLase Plus Table medical devices consists of: System Console, Operator control panel, Touch screen monitor, Power cable, Accessories and components. The XLase Plus offers the flexibility to perform different medical and aesthetic treatments due to different laser modules. Treatment parameters are set according to Indications for Use. A range of values is available for each parameter. The integrated safety functions prevent the selection of values outside this range.
Summary parsed at:2026-06-01 05:38:37 UTC
Predicate devices
5—
—
Not ingested
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
Deka Luxea
elysion-pro
GentleMax Pro Plus
K212790 references 5 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K212790 as a predicate
