Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT

Quanta System Spa

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

3

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K241092
Device name
Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-04-22
Decision date
2024-10-10
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) and accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

Surgical Handpieces Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with surgical handpieces are indicated for use for the particular indications as follows:
Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
* laser skin resurfacing
* laser derm-abrasion
* laser burn debridement.

Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.

Youlaser PRIME and Youlaser PRIME MT with wavelength of 1550nm used in combination with OptiScan PRIME scanner, are indicated for:
• Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue.

Intended Use

The Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) and accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).

Device Description

The models of the Youlaser PRIME family are medical laser emitting at 10600nm (CO2 laser source), 1550nm, plus combined configurations. The 1550nm laser source is a fiber laser, this wavelength lies in the invisible infrared part of the electromagnetic spectrum. The CO2 laser source is an RF driven sealed gas tube emitting laser radiation both in continuous and pulsed mode in the invisible far-infrared part of the electromagnetic spectrum (10600nm). The beam delivery system is an articulated arm with a handpiece or a scanner on its end. The laser device is equipped with a display with a graphical user interface (GUI) for user-device interaction (e.g. laser parameters settings). The scanner is also provided with a touchscreen display to select the scan pattern, shape, dimension,…etc. Laser emission is controlled via the external footswitch. The footswitch has an activation pedal which enables laser emission.

Summary parsed at:2026-06-01 05:28:10 UTC

Predicate devices

3

K241092 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K241092 as a predicate