PicoLO Nd: YAG Picosecond Laser System
FDA 510(k) clearance K203491 · decided 2021-04-07
Clearance details
- K-number
- K203491
- Device name
- PicoLO Nd: YAG Picosecond Laser System
- Applicant
- Laseroptek Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-27
- Decision date
- 2021-04-07
- Days to decision
- 131 days
- Clearance type
- Special
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Seongnam-Si, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.