Cleared Traditional

K811010 - CONTACT LENS MATERL

K811010 · Paragon Optical Co. · Ophthalmic device
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Dec 1981
Decision
238d
Days
-
Risk

K811010 is an FDA 510(k) clearance for the CONTACT LENS MATERL. Classified as Lens, Contact (polymethylmethacrylate) (product code HPX).

Submitted by Paragon Optical Co. (Mchenry, US). The FDA issued a Cleared decision on December 9, 1981 after a review of 238 days - an extended review 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: 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 - K811010

510(k) Number K811010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1981
Decision Date December 09, 1981
Days to Decision 238 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
128d slower than avg
Panel avg: 110d · This submission: 238d
Pathway characteristics
Predicate-based equivalence.

HPX Device Classification - Class 0,

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

Regulatory Peers - HPX Lens, Contact (polymethylmethacrylate)

All 42
Devices cleared under the same product code (HPX) and FDA review panel - the closest regulatory comparables to K811010.
BAUSCH & LOMB STERILE ALL PURPOSE SOLU
K820511 · Bausch & Lomb, Inc. · Apr 1982
CONCENTRATED CLEANER FOR HARD CONTACTS
K820818 · Bausch & Lomb, Inc. · Apr 1982
LENS-PAC
K813528 · The Plactory · Jan 1982
LENSINE EXTRA STRENGTH CLEANER
K812433 · CooperVision, Inc. · Sep 1981
BARNES-HIND WEEKLY CLEANER
K812135 · Barnes-Hind, Inc. · Aug 1981
CONTACT LENS CLEANER
K812172 · Alcon Laboratories · Aug 1981
K811010 · CONTACT LENS MATERL
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