Cleared Traditional

K981640 - S2LO

K981640 is an FDA 510(k) clearance for S2LO, manufactured by Odyssey Optical Systems, LLC. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K981640 · Odyssey Optical Systems, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
89d
Days
Class 2
Risk

K981640 is an FDA 510(k) clearance for the S2LO. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Odyssey Optical Systems, LLC (Weston, US). The FDA issued a Cleared decision on August 5, 1998 after a review of 89 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 Odyssey Optical Systems, LLC devices

FDA 510(k) Submission Details - K981640

510(k) Number K981640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1998
Decision Date August 05, 1998
Days to Decision 89 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 110d · This submission: 89d
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 59
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K981640.
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