510(k) K833533

LASER PHOTOCOAGULATOR 1520-A & K by Britt Corp., Inc. — Product Code HQF

K833533 is an FDA 510(k) premarket notification submitted by Britt Corp., Inc. for the device "LASER PHOTOCOAGULATOR 1520-A & K". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Britt Corp., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
October 11, 1983
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