Cleared Traditional

K910532 - URAM OPHTHALMIC LASER ENDOSCOPE

K910532 is an FDA 510(k) clearance for URAM OPHTHALMIC LASER ENDOSCOPE, manufactured by Martin S. Knopf Assoc., Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K910532 · Martin S. Knopf Assoc., Inc. · Ophthalmic device
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May 1991
Decision
109d
Days
Class 2
Risk

K910532 is an FDA 510(k) clearance for the URAM OPHTHALMIC LASER ENDOSCOPE. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Martin S. Knopf Assoc., Inc. (Marlboro, US). The FDA issued a Cleared decision on May 28, 1991 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4390 - 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 Martin S. Knopf Assoc., Inc. devices

FDA 510(k) Submission Details - K910532

510(k) Number K910532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1991
Decision Date May 28, 1991
Days to Decision 109 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 110d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQF Device Classification - Class 2, Special Controls

Product Code HQF Laser, Ophthalmic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQF Laser, Ophthalmic

All 144
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K910532.
HGM ILLUMINATING IMAGING ENDOCULAR PROBE
K931784 · Hgm, Inc. · Mar 1994
NIDEK MODEL AC-2300
K932836 · Nidek, Inc. · Nov 1993
HGM ASPIRATING ENDOOCULAR(TM) PROBE
K925663 · Hgm, Inc. · Aug 1993
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
K910805 · Heraeus Lasersonics, Inc. · May 1991
COMPAC(TM) DIODE LASERS
K904699 · Hgm Medical Laser Systems, Inc. · Apr 1991
CANDELA DIODE TRABECULOPLASTY LASER DTL
K910612 · Candela Laser Corp. · Mar 1991