Cleared Traditional

BQ/BM INTEGRATED LASER DELIVERY SYSTEM

K990665 · American Laser Corp. · Ophthalmic
May 1999
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K990665 is an FDA 510(k) clearance for the BQ/BM INTEGRATED LASER DELIVERY SYSTEM, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by American Laser Corp. (Salt Lake City, US). The FDA issued a Cleared decision on May 17, 1999, 76 days after receiving the submission on March 2, 1999. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K990665 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1999
Decision Date May 17, 1999
Days to Decision 76 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390