Cleared Traditional

K895196 - MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR

K895196 is an FDA 510(k) clearance for MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR, manufactured by Nidek, Inc.. The device is a Class 2 Ophthalmic device with product code HQF cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K895196 · Nidek, Inc. · Ophthalmic device
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Oct 1989
Decision
66d
Days
Class 2
Risk

K895196 is an FDA 510(k) clearance for the MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Nidek, Inc. (El Toro, US). The FDA issued a Cleared decision on October 16, 1989 after a review of 66 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 Nidek, Inc. devices

FDA 510(k) Submission Details - K895196

510(k) Number K895196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1989
Decision Date October 16, 1989
Days to Decision 66 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
44d faster than avg
Panel avg: 110d · This submission: 66d
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 143
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K895196.
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
NIDEK MODEL AKC-8000
K894273 · Nidek, Inc. · Aug 1989
CANDELA UPC LASER PHOTOCOAGULATOR
K893630 · Candela Laser Corp. · Aug 1989
COHERENT MARIE ARGON PHOTOCOAGULATOR
K893709 · Coherent Medical Group · Jun 1989