FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
DeepSkin (DEP100)
K Number: K252621
·
Decision May 8, 2026
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
77
Applicant Total
12
Review Days
262
Basic Information
- Device Name
- DeepSkin (DEP100)
- K Number
- K252621
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- El Global Trade, Ltd.
- Date Received
- August 19, 2025
- Decision Date
- May 8, 2026
- Product Code
- NFO
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | FDA class 2 | Neurology |
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|---|---|---|---|
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| K183260 | Sensilight Pro / Pistol IPL | Mar 18, 2019 | Substantially Equivalent |
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| K172181 | micro IPL | Oct 13, 2017 | Substantially Equivalent |
| K170637 | sensiFirm | Jul 14, 2017 | Substantially Equivalent |
| K170499 | sensiLift | Jun 15, 2017 | Substantially Equivalent |
| K161089 | sensiLight Mini | Jul 8, 2016 | Substantially Equivalent |
| K140381 | SENSILIGHT/ SENSILIGHT PLUS | Aug 8, 2014 | Substantially Equivalent |