510(k) K873460

OPHTHALAS DYE OPHTHALMIC LASER by Biophysic Medical, Inc. — Product Code HQF

K873460 is an FDA 510(k) premarket notification submitted by Biophysic Medical, Inc. for the device "OPHTHALAS DYE OPHTHALMIC LASER". The FDA issued a decision of Substantially Equivalent on October 29, 1987. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Biophysic Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1987
Date Received
August 28, 1987
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