510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K050638Substantially Equivalent

Lenstec Intraocular Lens (IOL) Injection System for Tetraflex Intraocular Lenses

Lenstec, Inc., St. Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050638 is the FDA 510(k) clearance record for LENSTEC INTRAOCULAR LENS (IOL) INJECTION SYSTEM FOR TETRAFLEX INTRAOCULAR LENSES, a class I device, cleared for Lenstec, Inc. on under FDA product code MSS (Folders And Injectors, Intraocular Lens (Iol)). FDA records list 6 510(k) clearances for Lenstec, Inc., from to . As of , FDA records show no recalls naming K050638.

Clearance record

Decision date
Received
(81 days to decision)
Product code
MSS Folders And Injectors, Intraocular Lens (Iol)
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Lenstec, Inc. 2870 Scherer Dr., Suite 300, St. Petersburg FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSS

Trailing 12 months
1 clearance under product code MSS in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MSS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260