Cleared Traditional

K904699 - COMPAC(TM) DIODE LASERS

K904699 is an FDA 510(k) clearance for COMPAC(TM) DIODE LASERS, manufactured by Hgm Medical Laser Systems, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K904699 · Hgm Medical Laser Systems, Inc. · Ophthalmic device
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Apr 1991
Decision
191d
Days
Class 2
Risk

K904699 is an FDA 510(k) clearance for the COMPAC(TM) DIODE LASERS. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Hgm Medical Laser Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 25, 1991 after a review of 191 days - an extended review cycle.

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 Hgm Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K904699

510(k) Number K904699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1990
Decision Date April 25, 1991
Days to Decision 191 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 110d · This submission: 191d
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 84
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K904699.
MEGABEAM ENDOCULAR PROBE
K935747 · Ceram Optec, Inc. · Apr 1994
NIDEK MODEL AC-2300
K932836 · Nidek, Inc. · Nov 1993
ND:YAG LASER SYSTEMS (VARIOUS MODELS)
K910805 · Heraeus Lasersonics, Inc. · May 1991
CANDELA DIODE TRABECULOPLASTY LASER DTL
K910612 · Candela Laser Corp. · Mar 1991
CENTAURI
K905141 · Pfizer Laser Systems · Feb 1991
MICROLASE BY LASER TRABECULOPLASTY
K895213 · Keeler Instruments, Inc. · Oct 1989