FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLEAR + BRILLIANT LASER SYSTEM
K Number: K120433
·
Decision Apr 2, 2012
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
34
Applicant Total
8
Review Days
49
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Basic Information
- Device Name
- CLEAR + BRILLIANT LASER SYSTEM
- K Number
- K120433
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solta Medical, Inc.
- Date Received
- February 13, 2012
- Decision Date
- April 2, 2012
- Product Code
- ONG
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Solta Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K223647 | CLEAR+BRILLIANT TOUCH® Laser System | Dec 29, 2022 | Substantially Equivalent |
| K132431 | THERMAGE CPT SYSTEM | Sep 6, 2013 | Substantially Equivalent |
| K130193 | FRAXEL DUAL 1550/1927 LASER SYSTEM | Jun 14, 2013 | Substantially Equivalent |
| K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM | Jun 5, 2012 | Substantially Equivalent |
| K110349 | CLEAR+BRILLIANT LASER SYSTEM | May 3, 2011 | Substantially Equivalent |
| K091420 | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 | Oct 14, 2009 | Substantially Equivalent |
| K090580 | THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES | Jun 26, 2009 | Substantially Equivalent |