FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
micro IPL
K Number: K172181
·
Decision Oct 13, 2017
Classifications
1
FEI Numbers
90
Registration Numbers
91
Same Product Code
161
Applicant Total
12
Review Days
86
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Basic Information
- Device Name
- micro IPL
- K Number
- K172181
- 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
- El Global Trade, Ltd.
- Date Received
- July 19, 2017
- Decision Date
- October 13, 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)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
IPL Hair Removal Device (Models: T31A, T32A)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by El Global Trade, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252621 | DeepSkin (DEP100) | May 8, 2026 | Substantially Equivalent |
| K250341 | Sensilift Pro (ST300XXYYZZZ) | Jan 6, 2026 | Substantially Equivalent |
| K250384 | IPL400 | May 23, 2025 | Substantially Equivalent |
| K232424 | CurrentBody Skin RF | Mar 6, 2024 | Substantially Equivalent |
| K183260 | Sensilight Pro / Pistol IPL | Mar 18, 2019 | Substantially Equivalent |
| K181095 | RF-Relief | Jul 24, 2018 | 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 |