FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
SILK'N
K Number: K072906
·
Decision Jan 23, 2008
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
10
Review Days
104
Basic Information
- Device Name
- SILK'N
- K Number
- K072906
- 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
- HOME SKINOVATIONS LTD.
- Date Received
- October 11, 2007
- Decision Date
- January 23, 2008
- 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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|---|---|---|---|
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| K120582 | HEATLUX | Jul 6, 2012 | Substantially Equivalent |
| K110301 | SILK'N FX | Aug 19, 2011 | Substantially Equivalent |
| K103184 | SILK'N FLASH N GO | Nov 10, 2010 | Substantially Equivalent |
| K082298 | FLASH N' GO | Oct 23, 2008 | Substantially Equivalent |