510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K991995Substantially Equivalent

Softchrome Tints, Transparent Tinted Soft Contact Lens

Softchrome, Inc., Grand Junction CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991995 is the FDA 510(k) clearance record for SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS, a class II device, cleared for Softchrome, Inc. on under FDA product code MZD (System, In-Office Tinting, Contact Lenses). FDA records list one 510(k) clearance for Softchrome, Inc. As of , FDA records show no recalls naming K991995.

Clearance record

Decision date
Received
(74 days to decision)
Product code
MZD System, In-Office Tinting, Contact Lenses
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Softchrome, Inc. 623 Glacier Dr., Grand Junction CO
510(k) summary
Summary
Third party review
No

Clearances, product code MZD

Trailing 12 months

FDA records hold no clearances under product code MZD in the trailing twelve months.

FDA records show no clearances under product code MZD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MZD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260