510(k) K791659

MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL by Coburn Optical Ind., Inc. — Product Code HQF

K791659 is an FDA 510(k) premarket notification submitted by Coburn Optical Ind., Inc. for the device "MEDITEC (RODENSTOCK) LASER PHOTOCOAGUL". The FDA issued a decision of Substantially Equivalent on October 11, 1979. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Coburn Optical Ind., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 1979
Date Received
August 22, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Ophthalmic
Device Class
Class II
Regulation Number
886.4390
Review Panel
OP
Submission Type