Cleared Traditional

K895213 - MICROLASE BY LASER TRABECULOPLASTY

K895213 is the FDA 510(k) clearance for MICROLASE BY LASER TRABECULOPLASTY by Keeler Instruments, Inc.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K895213 · Keeler Instruments, Inc. · Ophthalmic device
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Oct 1989
Decision
74d
Days
Class 2
Risk

K895213 is an FDA 510(k) clearance for the MICROLASE BY LASER TRABECULOPLASTY. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on October 31, 1989 after a review of 74 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 Keeler Instruments, Inc. devices

Submission Details

510(k) Number K895213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1989
Decision Date October 31, 1989
Days to Decision 74 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
36d faster than avg
Panel avg: 110d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K895213.
NIDEK MODEL GYC-1500 AND GYC-2000
K951079 · Nidek, Inc. · Sep 1995
KEELER MULTILASE 3000
K942180 · Keeler Instruments, Inc. · Nov 1994
NIDEK MODEL AC-2300
K932836 · Nidek, Inc. · Nov 1993
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR
K895196 · Nidek, Inc. · Oct 1989
NIDEK MODEL AKC-8000
K894273 · Nidek, Inc. · Aug 1989
MICROLASE 8 0 0 (OPHTHALMIC LASER)
K890086 · Keeler Instruments, Inc. · Mar 1989