FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
K Number: K101490
·
Decision Sep 8, 2010
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
34
Applicant Total
18
Review Days
99
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Basic Information
- Device Name
- FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US
- K Number
- K101490
- 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
- Thermage, Inc.
- Date Received
- June 1, 2010
- Decision Date
- September 8, 2010
- 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 Thermage, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K072849 | MODIFICATION TO THERMAGE THERMACOOL SYSTEM | Jan 18, 2008 | Substantially Equivalent |
| K052936 | THERMAGE THERMACOOL SYSTEM | Jun 12, 2007 | Substantially Equivalent |
| K061001 | THERMASSAGE | Oct 12, 2006 | Substantially Equivalent |
| K053365 | MODIFICATION TO THERMAGE THERMACOOL SYSTEM | Dec 13, 2005 | Substantially Equivalent |
| K052778 | THERMAGE THERMACOOL SKIN MARKETING | Oct 20, 2005 | Substantially Equivalent |
| K051710 | THERMAGE THERMACOOL COUPLING FLUID | Jul 19, 2005 | Substantially Equivalent |
| K043402 | THERMAGE THERMACOOL SYSTEM | Jan 14, 2005 | Substantially Equivalent |
| K040135 | THERMAGE THERMACOOL SYSTEM | Jun 21, 2004 | Substantially Equivalent |
| K033942 | THERMAGE THERMACOOL SYSTEM | Feb 4, 2004 | Substantially Equivalent |
| K032088 | MODIFICATION TO THERMACOOL TC SYSTEM | Aug 1, 2003 | Substantially Equivalent |