Cleared Traditional

K951437 - OTI MODEL TLS-60
(FDA 510(k) Clearance)

K951437 · Oti Medical, LLC · Ophthalmic device

Apr 1995

Decision

15d

Days

Class 1

Risk

K951437 is an FDA 510(k) clearance for the OTI MODEL TLS-60. This device is classified as a Set, Lens, Trial, Ophthalmic (Class I - General Controls, product code HPC).

Submitted by Oti Medical, LLC (Sacramento, US). The FDA issued a Cleared decision on April 11, 1995, 15 days after receiving the submission on March 27, 1995.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1405.

Submission Details

510(k) Number	K951437 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 1995
Decision Date	April 11, 1995
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement