Cleared Traditional

K952597 - VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW

K952597 is an FDA 510(k) clearance for VIEW POINT, manufactured by Point of View Optical Outlet, Inc.. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K952597 · Point of View Optical Outlet, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
98d
Days
Class 1
Risk

K952597 is an FDA 510(k) clearance for the VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, .... Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Point of View Optical Outlet, Inc. (Aventura, US). The FDA issued a Cleared decision on September 12, 1995 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K952597

510(k) Number K952597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1995
Decision Date September 12, 1995
Days to Decision 98 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
12d faster than avg
Panel avg: 110d · This submission: 98d
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 197
Devices cleared under the same product code (HQZ) and FDA review panel - the closest regulatory comparables to K952597.
SPECTACLE FRAME
K944313 · Sun Hing Optical Manufactory , Ltd. · Mar 1995
SPECTACLE FRAME OR EYEGLASS FRAMES
K945176 · Optipia Trading Co. · Dec 1994
SPECTACLE FRAME
K945392 · Seo Han Corp., Ltd. · Dec 1994
OPTICAL FRAMES
K945770 · Ramada Optics, Inc. · Dec 1994
FRAME, SPECTACLES
K945350 · Taiwan Eva Industrial Co., Inc. · Dec 1994
MAG-1 SPECTACLE FRAME
K945342 · Criss Optical Mfg. Co., Inc. · Nov 1994
K952597 · VIEW POINT, DORION, RUDDY PROJECT, ULTRA FLEX, TRILLON, BAY BOY, SHIELD SKI, SUN POCKETS, POINT OF VIEW
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