510(k) K813429

LASER PHOTOCOAGULATOR ARGON MED. LASER by American Laser Corp. — Product Code HPJ

K813429 is an FDA 510(k) premarket notification submitted by American Laser Corp. for the device "LASER PHOTOCOAGULATOR ARGON MED. LASER". The FDA issued a decision of Substantially Equivalent on January 22, 1982. The device falls under product code HPJ (Instrument, Visual Field, Laser), a Class II device regulated under 21 CFR 886.1360. American Laser Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 1982
Date Received
December 8, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Visual Field, Laser
Device Class
Class II
Regulation Number
886.1360
Review Panel
OP
Submission Type