FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO THERMAGE THERMACOOL SYSTEM
K Number: K053365
·
Decision Dec 13, 2005
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
18
Review Days
11
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Basic Information
- Device Name
- MODIFICATION TO THERMAGE THERMACOOL SYSTEM
- K Number
- K053365
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thermage, Inc.
- Date Received
- December 2, 2005
- Decision Date
- December 13, 2005
- Product Code
- GEI
- 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Thermage, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K101490 | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US | Sep 8, 2010 | Substantially Equivalent |
| 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 |
| 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 |