Cleared Traditional

K951079 - NIDEK MODEL GYC-1500 AND GYC-2000

K951079 is the FDA 510(k) clearance for NIDEK MODEL GYC-1500 AND GYC-2000 by Nidek, Inc.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K951079 · Nidek, Inc. · Ophthalmic device
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Sep 1995
Decision
189d
Days
Class 2
Risk

K951079 is an FDA 510(k) clearance for the NIDEK MODEL GYC-1500 AND GYC-2000. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Nidek, Inc. (Fremont, US). The FDA issued a Cleared decision on September 14, 1995 after a review of 189 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 Nidek, Inc. devices

Submission Details

510(k) Number K951079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1995
Decision Date September 14, 1995
Days to Decision 189 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 110d · This submission: 189d
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 79
Devices cleared under the same product code (HQF) and FDA review panel - the closest regulatory comparables to K951079.
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CERALAS DIODE LASER SYSTEM (CERALAS D2)
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VISULINK 900 ARGON
K952894 · Carl Zeiss, Inc. · Aug 1995
KEELER MULTILASE 3000
K942180 · Keeler Instruments, Inc. · Nov 1994
MEGABEAM ENDOCULAR PROBE
K935747 · Ceram Optec, Inc. · Apr 1994