Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233756 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
- Models / Variants
- RL-S20S-TWC FDA 510(k)RL-S20S-810B FDA 510(k)RL-S20S-755 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 Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) is a diode laser device classified under 21 CFR 878.4810 for use in general and plastic surgery, as well as dermatology. It delivers laser energy to selectively target hair follicles through the principle of selective photothermolysis, enabling permanent or temporary hair reduction.
This system is intended for clinical use in sterile environments and is supplied as a reusable medical device. It operates within regulatory parameters as a Class II device under the Product Code GEX, with FDA clearance via a 510(k) submission (K233756). Models include distinct wavelength configurations (TWC, 810B, 755) for tailored hair removal applications, adhering to safety standards for laser surgical instruments.
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: Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755 ..., PDF Na Wu Quality Manager 801,8F, E2Building, Future City, No.999 High-Tech ..., PDF K233756 Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755), Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233756 | Class II | Active |
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Manufacturer
- Manufacturer
- Rhein Laser Technologies Co., Ltd.
Sources (1)
- FDA 510(k) K233756 24 fields · synced Sep 19, 2026