FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRAXEL DUAL 1550/1927 LASER SYSTEM
K Number: K130193
·
Decision Jun 14, 2013
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
8
Review Days
140
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Basic Information
- Device Name
- FRAXEL DUAL 1550/1927 LASER SYSTEM
- K Number
- K130193
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Solta Medical, Inc.
- Date Received
- January 25, 2013
- Decision Date
- June 14, 2013
- Product Code
- GEX
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 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 |
| K121515 | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM | Jun 5, 2012 | Substantially Equivalent |
| K120433 | CLEAR + BRILLIANT LASER SYSTEM | Apr 2, 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 |