Identifiers
- 510(k) Number
- K082911 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SmoothCool HR System is an Intense Pulsed Light (IPL) device designed for hair removal and skin rejuvenation. It delivers controlled light energy to target hair follicles, enabling permanent hair reduction while also offering SR filters for non-ablative skin treatment. Classified under the FDA’s General, Plastic Surgery advisory committee, it operates as a non-laser alternative for dermatological applications.
The system is supplied as a trolley-mounted console with an integrated handpiece featuring a 10mm x 50mm spot size and active temperature control (ATC) for sub-zero cooling. It is intended for professional use in clinical or aesthetic settings and is cleared under FDA 510(k) (K082911) as substantially equivalent to a predicate device. No regulatory status beyond the stated clearance is implied.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Hair removal IPL system - SmoothCool - JEISYS Medical - trolley-mounted, SmoothCool HR - Not a Laser | Laser Hair Removal Map, SmoothCool HR System by Jeisys Medical Inc | FDA 510(k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082911 | Class II | Active |
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Manufacturer
- Manufacturer
- Jeisys Medical Inc.
- FDA Applicant
- Jeisys Medical, Inc.
Sources (1)
- FDA 510(k) K082911 24 fields · synced Oct 6, 2026