Cleared Traditional

LASER PHOTOCOAGULATOR ARGON MED. LASER

K813429 · American Laser Corp. · Hematology

Jan 1982

Decision

45d

Days

Class 2

Risk

About This 510(k) Submission

K813429 is an FDA 510(k) clearance for the LASER PHOTOCOAGULATOR ARGON MED. LASER, a Instrument, Visual Field, Laser (Class II — Special Controls, product code HPJ), submitted by American Laser Corp. (Mchenry, US). The FDA issued a Cleared decision on January 22, 1982, 45 days after receiving the submission on December 8, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 886.1360.

Submission Details

510(k) Number	K813429 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 1981
Decision Date	January 22, 1982
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—