Identifiers
- 510(k) Number
- K213484 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) system designed for hair removal, specifically for permanent hair reduction in dermatology. The system includes a console with a power unit, control electronics, and a control and display panel with software, along with applicators or hand pieces that generate light energy for treatment.
The device is supplied as a single-use system and is intended for use by trained professionals. It is not reusable and requires proper storage conditions. The system is regulated under FDA 510(k) clearance and is intended for use in dermatological procedures.
Frequently asked questions
What is the SmoothCool HR System used for?
The SmoothCool HR System is an Intense Pulsed Light (IPL) device designed for permanent hair reduction in dermatology. It is intended for use by trained professionals to treat patients.
Is the SmoothCool HR System reusable?
No, the SmoothCool HR System is supplied as a single-use system and is not reusable. It requires proper storage conditions and is intended for use by trained professionals.
What is the regulatory status of the SmoothCool HR System?
The SmoothCool HR System is regulated under FDA 510(k) clearance. It was found to be substantially equivalent to predicate devices and cleared for use in dermatological procedures.
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: SmoothCool HR System by Jeisys Medical Inc | FDA 510(k) Summary, K213484 FDA 510(k) - SmoothCool HR System | Jeisys Medical, Inc., SmoothCool HR System (K223685) - FDA 510 (k), SmoothCool HR - Not a Laser | Laser Hair Removal Map
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213484 | Class II | Active |
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Manufacturer
- Manufacturer
- Jeisys Medical Inc.
- FDA Applicant
- Jeisys Medical, Inc.
Sources (1)
- FDA 510(k) K213484 24 fields · synced Sep 21, 2026