Clear + Brilliant Laser System
FDA 510(k) K120433 · Solta Medical, Inc.
Submission
- Device name
- Clear + Brilliant Laser System
- Applicant
- Solta Medical, Inc.
Hayward, CA, US - Received
- February 13, 2012
- Decision date
- April 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONG – Powered Laser Surgical Instrument With MicrobeamFractional Output
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for…
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Questions and answers
When was Clear + Brilliant Laser System cleared by the FDA?
Clear + Brilliant Laser System (K120433) received a 510(k) decision of Substantially Equivalent on April 2, 2012, 49 days after the submission was received.
What is the product code of K120433?
The FDA product code is ONG – Powered Laser Surgical Instrument With MicrobeamFractional Output, a Class II (moderate risk) device regulated under 21 CFR 878.4810.