Manufacturer
Quanta System SpaYoulaser CO2
Country / Region:Italy (IT)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K182669
- Device name
- Youlaser CO2
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-09-25
- Decision date
- 2018-10-17
- Submission type
- Special
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
When used in traditional, non-fractionated mode for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.
Intended Use
When used in traditional, non-fractionated mode for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.
Device Description
YOULASER CO2 laser device has a CO2 laser source emitting at 10600 nm. The beam delivery is enabled through an articulated arm. Emission is triggered by means of the footswitch or the finger switch available on the scanner. An embedded PC is added to manage the GUI. A proprietary Scanner – Optiscan – is introduced. Emission is triggered also from a fingerswitch mounted on the scanner. Change to the GUI appearance. Change to the external panels.
Summary parsed at:2026-06-01 05:58:03 UTC
Predicate devices
1—
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Not ingested
K182669 references 1 predicate/reference device
Cited as predicate
1Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
1 submission cite K182669 as a predicate
