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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(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
1660 S. Loop Rd.
Alameda,  CA  94502
Applicant Contact Jennifer Mok
Correspondent
Convergent Laser Technologies
1660 S. Loop Rd.
Alameda,  CA  94502
Correspondent Contact Jennifer Mok
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/17/2021
Decision Date 11/09/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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