510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K094052Substantially Equivalent

Lensx 550 Laser System. Model 550

Lensx Lasers, Inc., Laguna Beach CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K094052 is the FDA 510(k) clearance record for LENSX 550 LASER SYSTEM. MODEL 550, a class II device, cleared for Lensx Lasers, Inc. on under FDA product code OOE (Ophthalmic Femtosecond Laser). FDA's definition for product code OOE reads: "Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery". FDA records list 4 510(k) clearances for Lensx Lasers, Inc., from to . As of , FDA records show no recalls naming K094052.

Clearance record

Decision date
Received
(113 days to decision)
Product code
OOE Ophthalmic Femtosecond Laser
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
Lensx Lasers, Inc. 733 Bolsana Dr., Laguna Beach CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOE

Trailing 12 months

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

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