Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
FDA 510(k) clearance K211517 · decided 2021-11-09
Clearance details
- K-number
- K211517
- Device name
- Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories
- Applicant
- Convergent Laser Technologies
- Decision
- Substantially Equivalent
- Date received
- 2021-05-17
- Decision date
- 2021-11-09
- Days to decision
- 176 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
- Alameda, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.