FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Silk'n Infinity
K Number: K171433
·
Decision Aug 11, 2017
Classifications
1
FEI Numbers
90
Registration Numbers
91
Same Product Code
161
Applicant Total
15
Review Days
88
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Basic Information
- Device Name
- Silk'n Infinity
- K Number
- K171433
- 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
- May 15, 2017
- Decision Date
- August 11, 2017
- Product Code
- OHT
- 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 |
|---|---|---|---|
| OHT | Light Based Over-The-Counter Hair Removal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OHT), ordered by most recent decision date.
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
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Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025)
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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 |
| K180279 | Silk'n MODEL H5003 device | May 9, 2018 | 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 |