Spectacle Frames

by Custom Optical Frames, Inc. 510(k)

Active United States

510(k) K944373

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK944373	Date28 Sep 1994Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K944373
FDA Product Code: HQZ

Device Class: Class I
Regulation: 21 CFR Part 886.5842
Advisory Committee: Ophthalmic
FDA Decision: SESE Substantially Equivalent

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