Cleared Traditional

MQL 20 ND:YAG OPHTHALMIC LASER

K884694 · California Laboratories, Inc. · Ophthalmic
Nov 1988
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K884694 is an FDA 510(k) clearance for the MQL 20 ND:YAG OPHTHALMIC LASER, a Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (Class II — Special Controls, product code LQJ), submitted by California Laboratories, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 30, 1988, 21 days after receiving the submission on November 9, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K884694 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1988
Decision Date November 30, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code LQJ — Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390

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