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
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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.

View all Point of View Optical Outlet, Inc. devices

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
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 7
Devices cleared under the same product code (HQZ) and FDA review panel - the closest regulatory comparables to K952597.
OPTHALMIC WIPE
K942897 · Surgin Surgical Instrumentation, Inc. · Aug 1994
SPECTACLE FRAME - DANIELLE
K871688 · Roseburg SA · May 1987
SPECTACLE FRAME - LORRAINE
K871689 · Roseburg SA · May 1987
EYE BARRIER
K863182 · O.R. Concepts, Inc. · Sep 1986
SPECTACLES FRAME
K860954 · Roseburg SA · Mar 1986
SPECTACLE FRAME, OP-TITE
K772368 · Dentsply Intl. · Jan 1978