Cleared Traditional

K942463 - FRAME, SPECTACLE

K942463 is an FDA 510(k) clearance for FRAME, manufactured by Erica Optical Co.. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K942463 · Erica Optical Co. · Ophthalmic device
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Jul 1994
Decision
49d
Days
Class 1
Risk

K942463 is an FDA 510(k) clearance for the FRAME, SPECTACLE. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Erica Optical Co. (Sakai Gun, Fukui-Pref, JP). The FDA issued a Cleared decision on July 12, 1994 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5842 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K942463

510(k) Number K942463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1994
Decision Date July 12, 1994
Days to Decision 49 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 110d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

HQZ Device Classification - Class 1, General Controls

Product Code HQZ Frame, Spectacle
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.5842
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HQZ Frame, Spectacle

All 184
Devices cleared under the same product code (HQZ) and FDA review panel - the closest regulatory comparables to K942463.
SEIKO EYEGLASS FRAME
K942513 · Seiko Optical Products of America, Inc. · Jul 1994
EYECOTECH CORP
K941414 · Eyecotech Corp. · Jul 1994
PAUL SMITH SPECTACLES LTD. BY OLIVER PEOPLES, INC.
K942348 · Oliver Peoples, Inc. · Jul 1994
SPECTACLE FRAMES (V.I.P. INT'L)
K940733 · Continental Optical Imports · Jun 1994
SPECTACLE FRAMES
K941211 · H & M Optical (U.S.A.) , Ltd. · Jun 1994
SPECTACLE FRAMES, READING GLASSES
K941463 · Well Arts Optical Factory , Ltd. · Jun 1994
K942463 · FRAME, SPECTACLE
Download PDF Erica Optical Co.