FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CABOCHON SYSTEM
K Number: K134010
·
Decision Apr 14, 2014
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
8
Applicant Total
2
Review Days
105
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Basic Information
- Device Name
- CABOCHON SYSTEM
- K Number
- K134010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4790
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cabochon Aesthetics, Inc.
- Date Received
- December 30, 2013
- Decision Date
- April 14, 2014
- Product Code
- OUP
- 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 |
|---|---|---|---|
| OUP | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Cabochon Aesthetics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN110004 | CABOCHON SYSTEM | Jul 12, 2013 | Unknown |