Cleared Traditional

K910612 - CANDELA DIODE TRABECULOPLASTY LASER DTL

K910612 is an FDA 510(k) clearance for CANDELA DIODE TRABECULOPLASTY LASER DTL, manufactured by Candela Laser Corp.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K910612 · Candela Laser Corp. · Ophthalmic device
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Mar 1991
Decision
20d
Days
Class 2
Risk

K910612 is an FDA 510(k) clearance for the CANDELA DIODE TRABECULOPLASTY LASER DTL. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on March 4, 1991 after a review of 20 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Candela Laser Corp. devices

FDA 510(k) Submission Details - K910612

510(k) Number K910612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1991
Decision Date March 04, 1991
Days to Decision 20 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 110d · This submission: 20d
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 139
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K910612.
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
CENTAURI
K905141 · Pfizer Laser Systems · Feb 1991
MICROLASE BY LASER TRABECULOPLASTY
K895213 · Keeler Instruments, Inc. · Oct 1989
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
K895196 · Nidek, Inc. · Oct 1989