Cleared Traditional

INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM

K883719 · Biophysic Medical, Inc. · Ophthalmic
Oct 1988
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K883719 is an FDA 510(k) clearance for the INTERCONN. OF OPHTHALAS & NANOLAS LASER SYSTEM, a Lens, Surgical, Laser, Accesssory, Ophthalmic Laser (Class II — Special Controls, product code LQJ), submitted by Biophysic Medical, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on October 18, 1988, 48 days after receiving the submission on August 31, 1988. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K883719 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1988
Decision Date October 18, 1988
Days to Decision 48 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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