Cleared Traditional

K882517 - RODENSTOCK SCANNING LASER OPHTHALMOSCOPE

K882517 is an FDA 510(k) clearance for RODENSTOCK SCANNING LASER OPHTHALMOSCOPE, manufactured by Rodenstock Instrument Corp.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 221-day FDA review.

K882517 · Rodenstock Instrument Corp. · Ophthalmic device
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Jan 1989
Decision
221d
Days
Class 2
Risk

K882517 is an FDA 510(k) clearance for the RODENSTOCK SCANNING LASER OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Rodenstock Instrument Corp. (Boston, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 221 days - an extended review 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: 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.

FDA 510(k) Submission Details - K882517

510(k) Number K882517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1988
Decision Date January 24, 1989
Days to Decision 221 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 110d · This submission: 221d
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 82
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K882517.
MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE
K895010 · Mentor O & O, Inc. · Sep 1989
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
K893172 · Keeler Instruments, Inc. · Jun 1989
VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)
K893173 · Keeler Instruments, Inc. · Jun 1989
THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE
K854244 · Keeler Instruments, Inc. · Nov 1985
AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP
K851263 · American Medical Optics · May 1985
AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS
K851264 · American Medical Optics · May 1985
K882517 · RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
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