XLase Plus

Biotec Italia, Srl

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

5

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K212790
Device name
XLase Plus
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

K212790 references 5 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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