510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K002647Substantially Equivalent

Marietta Contact Lens Service, Color Enhanced Tinted Soft Contact Lens

Marietta Contact Lens Service, Grand Junction CO / Traditional, Substantially Equivalent

K002647 is the FDA 510(k) clearance record for MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS, a class II device, cleared for Marietta Contact Lens Service on under FDA product code LPL (Lenses, Soft Contact, Daily Wear). FDA records list one 510(k) clearance for Marietta Contact Lens Service. As of , FDA records show no recalls naming K002647.

Clearance record

Decision date
Received
(20 days to decision)
Product code
LPL Lenses, Soft Contact, Daily Wear
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Marietta Contact Lens Service 623 Glacier Dr., Grand Junction CO
510(k) summary
Summary
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