FDA Registration
Active
🇰🇷 South Korea
CLASSYS INC
Reg #: 3010363436
·
FEI: 3010363436
·
Expires 2026
Products
8
Proprietary Names
13
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- CLASSYS INC
- Registration Number
- 3010363436
- FEI Number
- 3010363436
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9F, 25, Deokcheon-ro 152beon-gil, Manan-gu
- City
- Anyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K182355
Owner / Operator
- Firm Name
- CLASSYS INC
- Operator Number
- 10051595
- Address
- CLASSYS, 208, Teheran-ro, Gangnam-gu
- City
- Seoul
- State
- KR-11
- Postal Code
- 06220
- Country
- KR
- Correspondent
- James Lim
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Epilator, High Frequency, Needle-Type | KCW | Class 1 | General, Plastic Surgery | No | 2024-10-29 |
| Electrosurgical Coagulation For Aesthetic | ONQ | Class 2 | General, Plastic Surgery | No | 2024-10-29 |
| Skin Resurfacing Rf Applicator | OUH | Class 2 | General, Plastic Surgery | No | 2024-10-29 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-10-29 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2024-10-29 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | Class 2 | General, Plastic Surgery | No | 2024-10-29 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2024-12-23 |
| Camera, Ophthalmic, Ac-Powered | HKI | Class 2 | Ophthalmic | No | 2024-10-29 |
Proprietary Names
Secret Rf Smartcure Applicator With Electrodes
Secret Duo
CuRAS hybrid
Secret Pro
Fraxis Duo
Curas Nd:Yag Laser
Vikini Diode Laser System
Acutron
Reepot
QUADESSY
Fraxis
Reticapture
Secret RF
Establishment Types
Manufacture Medical Device