Cleared Traditional

K860011 - NIDEK AC-2000 LASER SYSTEM

K860011 is an FDA 510(k) clearance for NIDEK AC-2000 LASER SYSTEM, manufactured by Nidek, Inc.. The device is a Class 2 Ophthalmic device with product code HQB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K860011 · Nidek, Inc. · Ophthalmic device
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Feb 1986
Decision
35d
Days
Class 2
Risk

K860011 is an FDA 510(k) clearance for the NIDEK AC-2000 LASER SYSTEM. Classified as Photocoagulator And Accessories (product code HQB), Class II - Special Controls.

Submitted by Nidek, Inc. (Palo Alto, US). The FDA issued a Cleared decision on February 7, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4690 - 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 - K860011

510(k) Number K860011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1986
Decision Date February 07, 1986
Days to Decision 35 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
75d faster than avg
Panel avg: 110d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQB Device Classification - Class 2, Special Controls

Product Code HQB Photocoagulator And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4690
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 - HQB Photocoagulator And Accessories

All 24
Devices cleared under the same product code (HQB) and FDA review panel - the closest regulatory comparables to K860011.
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION
K882679 · Surgical Laser Technologies, Inc. · Dec 1988
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION
K882441 · Surgical Laser Technologies, Inc. · Sep 1988
REUSABLE FIBEROPTIC LIGHTPIPE
K881926 · Advanced Surgical Products, Inc. · Jun 1988
SYSTEM 930 ARGON PHOTOCOAGULATOR
K844356 · Coherent Medical Group · May 1985
ARGON/KRYPTON LASER SYSTEM 8500
K844209 · Cooper Lasersonics, Inc. · Feb 1985
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS
K844197 · Nidek, Inc. · Dec 1984