Cleared Traditional

K820818 - CONCENTRATED CLEANER FOR HARD CONTACTS

K820818 · Bausch & Lomb, Inc. · Ophthalmic device
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Apr 1982
Decision
16d
Days
-
Risk

K820818 is an FDA 510(k) clearance for the CONCENTRATED CLEANER FOR HARD CONTACTS. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 9, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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 Bausch & Lomb, Inc. devices

Submission Details

510(k) Number K820818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1982
Decision Date April 09, 1982
Days to Decision 16 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
94d faster than avg
Panel avg: 110d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPX Lens, Contact (polymethylmethacrylate)
Device Class -

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 7
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K820818.
SENSITIVE EYES
K832706 · Bausch & Lomb, Inc. · Oct 1983
CLERZ LUBRICATING & REWETTING EYE DROPS
K830740 · CooperVision, Inc. · Jun 1983
BAUSCH & LOMB STERILE ALL PURPOSE SOLU
K820511 · Bausch & Lomb, Inc. · Apr 1982
LENSINE EXTRA STRENGTH CLEANER
K812433 · CooperVision, Inc. · Sep 1981
CONTACT LENS CLEANER
K812172 · Alcon Laboratories · Aug 1981