Manufacturer
Acclaro CorporationUltraClear Laser System (N/A)
Country / Region:United States (US)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
- K233803
- Device name
- UltraClear Laser System (N/A)
- Company
- Acclaro Corporation
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-11-29
- Decision date
- 2024-05-08
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Skin resurfacingVascular treatment
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia. The UltraClear Fractional Laser System with its accessories when used in Ultra mode is intended to produce fractional effects during skin resurfacing.
Intended Use
The UltraClear Fractional Laser System with its accessories is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytids, furrows, fine lines, textural irregularities, epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision (including acne scars), benign pigmented lesions, and vascular dyschromia. The UltraClear Fractional Laser System with its accessories when used in Ultra mode is intended to produce fractional effects during skin resurfacing.
Device Description
The UltraClear Fractional Laser System is substantially equivalent in design, function, operating principles, and intended use to the Joule ProFractional System (K173285).
Summary parsed at:2026-06-01 05:27:05 UTC
Predicate devices
2JOULE SYSTEM
UltraClear Fractional Laser System
K233803 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K233803 as a predicate