FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Silk'n MODEL H5003 device
K Number: K180279
·
Decision May 9, 2018
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
15
Review Days
98
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Basic Information
- Device Name
- Silk'n MODEL H5003 device
- K Number
- K180279
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Home Skinovations , Ltd.
- Date Received
- January 31, 2018
- Decision Date
- May 9, 2018
- Product Code
- NGX
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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Other Clearances by Home Skinovations , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K214078 | Silkn Toothwave | Jan 13, 2023 | Substantially Equivalent |
| DEN190039 | ToothWave | Sep 17, 2020 | Unknown |
| K171433 | Silk'n Infinity | Aug 11, 2017 | Substantially Equivalent |
| K162784 | Silk'n HST | Mar 25, 2017 | Substantially Equivalent |
| K152087 | HeatLux Pro II | Jul 29, 2016 | Substantially Equivalent |
| K150175 | HeatLux Pro I | Mar 31, 2015 | Substantially Equivalent |
| K141242 | GLIDE DEVICE | Oct 17, 2014 | Substantially Equivalent |
| K131870 | GLIDE DEVICE | Aug 14, 2013 | Substantially Equivalent |
| K121435 | SILKN BLUE | Feb 22, 2013 | Substantially Equivalent |
| K120582 | HEATLUX | Jul 6, 2012 | Substantially Equivalent |