Cleared Traditional

K822104 - ALCON INDIRECT OPHTHALMOSCOPE

K822104 is an FDA 510(k) clearance for ALCON INDIRECT OPHTHALMOSCOPE, manufactured by Alcon Laboratories. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K822104 · Alcon Laboratories · Ophthalmic device
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Aug 1982
Decision
22d
Days
Class 2
Risk

K822104 is an FDA 510(k) clearance for the ALCON INDIRECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Alcon Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 10, 1982 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - 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 Alcon Laboratories devices

FDA 510(k) Submission Details - K822104

510(k) Number K822104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1982
Decision Date August 10, 1982
Days to Decision 22 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
88d faster than avg
Panel avg: 110d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 - HLI Ophthalmoscope, Ac-powered

All 69
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K822104.
WOODLYN CLASSIC JAVAL OPHTHALMOMETER
K841764 · Woodlyn, Inc. · Aug 1984
WOODLYN CLASSIC KERATOMETER
K841767 · Woodlyn, Inc. · Aug 1984
WOODLYN SLIT LAMP HSSL-EC
K841763 · Woodlyn, Inc. · Aug 1984
OPHTHALMOSCOPE, BINOCULAR, INDIRECT
K772214 · Varian Assoc., Inc. · Dec 1977
OPHTHALMOSCOPE, MODEL #11100
K770768 · Welch Allyn, Inc. · May 1977