Cleared Traditional

K897091 - FRAME, SPECTACLE

K897091 is an FDA 510(k) clearance for FRAME, manufactured by Pt Midas Surya Optical Co.. The device is a Class 1 Ophthalmic device with product code HQZ cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K897091 · Pt Midas Surya Optical Co. · Ophthalmic device
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Jun 1990
Decision
176d
Days
Class 1
Risk

K897091 is an FDA 510(k) clearance for the FRAME, SPECTACLE. Classified as Frame, Spectacle (product code HQZ), Class I - General Controls.

Submitted by Pt Midas Surya Optical Co. (Jakarta 13930 Indonesia, ID). The FDA issued a Cleared decision on June 14, 1990 after a review of 176 days - an extended review 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: 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 Pt Midas Surya Optical Co. devices

FDA 510(k) Submission Details - K897091

510(k) Number K897091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1989
Decision Date June 14, 1990
Days to Decision 176 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 110d · This submission: 176d
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 K897091.
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