510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863367Substantially Equivalent for Some Indications

Formalens 2000

Cogentix Medical, Inc., Monrovia CA / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K863367 is the FDA 510(k) clearance record for FORMALENS 2000, a class I device, cleared for Vision-Sciences, Inc. on under FDA product code HQG (Lens, Spectacle, Non-Custom (Prescription)). FDA records list 35 510(k) clearances for COGENTIX MEDICAL, INC., from to . As of , FDA records show no recalls naming K863367.

Clearance record

Decision date
Received
(23 days to decision)
Product code
HQG Lens, Spectacle, Non-Custom (Prescription)
Regulation
21 CFR 886.5844
Device class
Class I
Review panel
Ophthalmic
Applicant
Vision-Sciences, Inc. 140 E. Duarte Rd., Monrovia CA
Third party review
No

Clearances, product code HQG

Trailing 12 months

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

FDA records show no clearances under product code HQG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQG, 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