Cleared Traditional

OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES (K000998) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000998 · Optisonic, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
74d
Days
Class 2
Risk

K000998 is an FDA 510(k) clearance for the OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CO.... Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Optisonic, Inc. (Chicago, US). The FDA issued a Cleared decision on June 5, 2000 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 Optisonic, Inc. devices

Submission Details

510(k) Number K000998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2000
Decision Date June 05, 2000
Days to Decision 74 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 110d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LPN Accessories, Soft Lens Products

All 119
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K000998.
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops
K222541 · Bausch & Lomb, Incorporated · Dec 2022
Aqua Naina Plus Sterile Saline Solution
K221263 · Chemtex USA, Inc. · Oct 2022
ABT12 multi-purpose solution
K202932 · Bausch & Lomb, Incorporated · May 2021
OTE MPS 045 Multi-purpose Lens Care Solution
K210051 · Ote North America, LLC · May 2021
Aqua Naina Sterile Saline Solution
K193441 · Chemtex USA, Inc. · May 2020
PuriLens Plus Preservative Free Saline
K200747 · The Lifestyle Company, Inc. · May 2020