CLARITY II Laser System
FDA 510(k) clearance K183566 · decided 2019-06-14
Clearance details
- K-number
- K183566
- Device name
- CLARITY II Laser System
- Applicant
- Lutronic Corporation
- Decision
- Substantially Equivalent
- Date received
- 2018-12-21
- Decision date
- 2019-06-14
- Days to decision
- 175 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Deogyang-Gu, Goyang-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CLARITY II Laser System; Model No. 1110200210. recall (Z-1558-2026) | Lutronic Corporation | 2026-03-12 |