Manufacturer
Solta MedicalCLEAR+BRILLIANT TOUCH® Laser System
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
- K223647
- Device name
- CLEAR+BRILLIANT TOUCH® Laser System
- Company
- Solta Medical
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-12-06
- Decision date
- 2022-12-29
- Submission type
- Traditional
- Technology type
- Er:YAG(AI inferred)
- Clinical applications
- Skin resurfacingOther
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
The CLEAR + BRILLIANT TOUCH® Laser System is intended for dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
Intended Use
The CLEAR + BRILLIANT TOUCH® Laser System is indicated for use in dermatological procedures requiring the coagulation of soft tissue and general skin resurfacing procedures.
Device Description
The CLEAR + BRILLIANT TOUCH® Laser System is the second generation of the Clear+Brilliant line of products. Clear+Brilliant products use non-ablative laser designed for use in dermatological procedures intended to improve the appearance of a patient's skin. The system incorporates self-diagnostic algorithms to ensure its correct operation. The CLEAR + BRILLIANT TOUCH® Laser System is part of the family of Solta Medical products using the fractional photothermolysis principle to resurface the skin. The system is comprised of four sub-systems: 1. Console 2. Handpieces: 1440nm and 1927nm (Perméa) handpieces 3. Treatment Tip 4. Credit Key. The console and up to two handpieces are connected mechanically and electrically by an umbilical cable. The treatment tip is mechanically and magnetically secured to the handpiece. All components must be properly connected and fully functional for the system to be operable. The system will not permit laser energy output until the treatment tip is in contact with the patient's skin. The embedded processor and software control the precise delivery of the fractional laser treatment by directing the electrical and mechanical components that determine the position, spacing, and focus of the optical output. The processor and software also monitor the status of a treatment and the system and present this information to the operator on the touchscreen. The Credit Key is the replaceable accessory allowing access to treatment credits and is attachable to the console. It is removable and is disposed of after the credit balance reaches zero. The solid-state design of CLEAR + BRILLIANT TOUCH® Laser System limits maintenance and minimizes utility requirements.
Summary parsed at:2026-06-01 05:40:37 UTC
