Cleared Traditional

K872846 - NIDEK ADC-8000 LASER SYSTEM

K872846 is the FDA 510(k) clearance for NIDEK ADC-8000 LASER SYSTEM by Nidek, Inc.. It is a Class 2 Ophthalmic device (product code HQF) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K872846 · Nidek, Inc. · Ophthalmic device
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Oct 1987
Decision
87d
Days
Class 2
Risk

K872846 is an FDA 510(k) clearance for the NIDEK ADC-8000 LASER SYSTEM. Classified as Laser, Ophthalmic (product code HQF), Class II - Special Controls.

Submitted by Nidek, Inc. (Palo Alto, US). The FDA issued a Cleared decision on October 15, 1987 after a review of 87 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

Submission Details

510(k) Number K872846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1987
Decision Date October 15, 1987
Days to Decision 87 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
23d faster than avg
Panel avg: 110d · This submission: 87d
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 K872846.
SLT CONTACT LASER SYSTEM OCULOPLASTICS
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PRISMA DISPOSABLE ENDO-OCULAR PROBE
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K874609 · Carl Zeiss, Inc. · Jan 1988
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
K870839 · Directed Energy, Inc. · May 1987
MODEL 1000 OPHTHALMIC LASER SYSTEM
K862987 · CooperVision, Inc. · Sep 1986
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
K854949 · CooperVision, Inc. · Feb 1986