510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K122220Substantially Equivalent

Eni-Eye Sh Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus and Irregular Cor Eni-Eye Sh Soft K Toric S

Soflex Limited, Littleton CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K122220 is the FDA 510(k) clearance record for ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S, a class II device, cleared for Soflex Limited on under FDA product code LPL (Lenses, Soft Contact, Daily Wear). FDA records list 3 510(k) clearances for Soflex Limited, from to . As of , FDA records show no recalls naming K122220.

Clearance record

Decision date
Received
(237 days to decision)
Product code
LPL Lenses, Soft Contact, Daily Wear
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Soflex Limited 33 Golden Eagle Ln., Littleton CO
510(k) summary
Statement
Third party review
No

Clearances, product code LPL

Trailing 12 months
9 clearances under product code LPL in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code LPL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20262
April 20261
May 20263
June 20260
July 20260
August 20260
September 20261
October 20260