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Sign in to claim this brandWhat CLASSYS Inc. makes
CLASSYS Inc. manufactures devices for dermatological and surgical procedures, including intradermal radio-frequency ablation systems like the Wav30 and Fraxis Main Unit, as well as carbon dioxide and solid-state laser systems such as the Secret PRO Set Package and Max-64C. Their portfolio also includes radio-frequency skin contouring applicators (e.g., VOLNEWMER F tip and VOLNEWMER S tip) and electrosurgical tools, including monopolar single-use electrodes and electrosurgical systems. Diode and frequency-doubled solid-state laser systems (e.g., QUADESSY Neutral and Deeplus hand pieces) are also part of their offerings.
CLASSYS Inc.’s devices are classified as Class II under US regulations and are listed in the FDA’s 510(k) and UDI registries. The company is based in the United States, where these products are authorised for commercial distribution.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- classys.com
- —
- —
- [email protected]
- Phone
- +82215443481
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 689842183
Catalogue (71)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CuRAS Zoom MLA Handpiece | QND-C1 | FDA UDI | Class II | Active |
| Reepot Handpiece | VSLS | FDA UDI | Class II | Active |
| QUADESSY Wavplus hand piece | QD1-M400 | FDA UDI | Class II | Active |
| QUADESSY Main Unit | QD1-M400 | FDA UDI | Class II | Active |
| Secret DUO Laser Handpiece | MTR3.0 | FDA UDI | Class II | Active |
| Fraxis Zoom Handpiece | FRX-C1 | FDA UDI | Class II | Active |
| CuRAS Main Unit | QND-C1 | FDA UDI | Class II | Active |
| CuRAS Collimation Handpiece | QND-C1 | FDA UDI | Class II | Active |
| Fraxis Duo Scanner Handpiece | FRX-C2 | FDA UDI | Class II | Active |
| CuRAS Zoom Handpiece | QND-C1 | FDA UDI | Class II | Active |
| CuRAS Set Package | QND-C1 | FDA UDI | Class II | Active |
| VOLNEWMER V tip(D) | VLMC04002D | FDA UDI | Class II | Active |
| Secret PRO Needle Hanpdiece | FRX-C2 | FDA UDI | Class II | Active |
| VOLNEWMER V tip | VLMC04002R | FDA UDI | Class II | Active |
| QUADESSY Smartcure(Basic) hand piece | QD1-M400 | FDA UDI | Class II | Active |
| Fraxis Duo Main Unit | FRX-C2 | EUDAMEDFDA UDI | Class II | Active |
| Max-M25 | MAX-M25 | FDA UDI | Class II | Active |
| Mtr-Ac-27g | MTR-AC-27G | FDA UDI | Class II | Active |
| Mtr-Ac-04 | MTR-AC-04 | FDA UDI | Class II | Active |
| Scizer (sc1-M410) | K230100 | FDA 510(k) | Class II | Active |
| CuRAS hybrid | K253123 | FDA 510(k) | Class II | Active |
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