Cleared Traditional

LOOK LENS LOOPS

K870440 · Look, Inc. · Ophthalmic
Feb 1987
Decision
17d
Days
Class 1
Risk

About This 510(k) Submission

K870440 is an FDA 510(k) clearance for the LOOK LENS LOOPS, a Hook, Ophthalmic (Class I — General Controls, product code HNQ), submitted by Look, Inc. (Boston, US). The FDA issued a Cleared decision on February 20, 1987, 17 days after receiving the submission on February 3, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K870440 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1987
Decision Date February 20, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary —

Device Classification

Product Code HNQ — Hook, Ophthalmic
Device Class Class I — General Controls
CFR Regulation 21 CFR 886.4350

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