510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993252Substantially Equivalent

Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to Be Marketed Yr. 2000), Frequency 55 Asp

CooperVision, Inc., Scottsville, NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993252 is the FDA 510(k) clearance record for METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP, a class II device, cleared for CooperVision, Inc. on under FDA product code MVN (Lens, Contact, (Disposable)). FDA records list 97 510(k) clearances for CooperVision, Inc., from to . As of , FDA records show no recalls naming K993252.

Clearance record

Decision date
Received
(57 days to decision)
Product code
MVN Lens, Contact, (Disposable)
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
CooperVision, Inc. 711 N. Rd., Scottsville, NY
510(k) summary
Summary
Third party review
No

Clearances, product code MVN

Trailing 12 months
1 clearance under product code MVN in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MVN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260