Cleared Traditional

BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY

K003933 · Polymer Technology · Ophthalmic
Feb 2001
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K003933 is an FDA 510(k) clearance for the BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY, a Lens, Contact (orthokeratology) (Class II — Special Controls, product code MUW), submitted by Polymer Technology (Rochester, US). The FDA issued a Cleared decision on February 16, 2001, 58 days after receiving the submission on December 20, 2000. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K003933 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2000
Decision Date February 16, 2001
Days to Decision 58 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code MUW — Lens, Contact (orthokeratology)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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