510(k) K842251

AMERI. MEDICAL OPTICS ARGON LASER PHOTO by American Medical Optics — Product Code HQF

K842251 is an FDA 510(k) premarket notification submitted by American Medical Optics for the device "AMERI. MEDICAL OPTICS ARGON LASER PHOTO". The FDA issued a decision of Substantially Equivalent on August 15, 1984. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. American Medical Optics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 1984
Date Received
May 30, 1984
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