Identity
- Trade Name
- Sensilight Pro - bronze FDA UDI
- Generic Name
- Intense pulsed light skin surface treatment system FDA UDI
- Device Name
- The Sensilight Pro is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured 6, 9 and 12 months after the completion of treatment regimen. FDA UDI
- Model / Reference
- IPL300US04SNS FDA UDI
- Description
- The Sensilight Pro is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured 6, 9 and 12 months after the completion of treatment regimen. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060445341576 FDA UDI
- 510(k) Number
- K183260 FDA UDI
- FDA Product Code
- OHT FDA UDIONF FDA UDI
- GMDN Term
- Intense pulsed light skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intense pulsed light skin surface treatment system
Sensilight Pro - bronze by El Global Trade Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- El Global Trade Ltd
Sources (1)
- FDA UDI 4b9dfc93-6358-4f44-b300-10a307ac917c 35 fields · synced May 30, 2026