510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133079Substantially Equivalent

Io2 Spher(mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear,io2 Toric (Mangofilcon a) Soft (Hydrophilic)

Alden Optical Labs., Inc., Golden CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133079 is the FDA 510(k) clearance record for IO2 SPHER(MANGOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IO2 TORIC (MANGOFILCON A) SOFT (HYDROPHILIC), a class II device, cleared for Alden Optical Labs., Inc. on under FDA product code LPL (Lenses, Soft Contact, Daily Wear). FDA records list 10 510(k) clearances for Alden Optical Labs., Inc., from to . As of , FDA records show no recalls naming K133079.

Clearance record

Decision date
Received
(78 days to decision)
Product code
LPL Lenses, Soft Contact, Daily Wear
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Alden Optical Labs., Inc. 16576 W. 53rd Way, Golden CO
510(k) summary
Summary PDF
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