510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901605Substantially Equivalent

Phoenix Laser Systems Ophthalmic Surgical Worksta.

Phoenix Laser Systems, Inc., St.Petersburg FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901605 is the FDA 510(k) clearance record for PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA., a class II device, cleared for Phoenix Laser Systems, Inc. on under FDA product code LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla). FDA records list one 510(k) clearance for Phoenix Laser Systems, Inc. As of , FDA records show no recalls naming K901605.

Clearance record

Decision date
Received
(252 days to decision)
Product code
LXS Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Regulation
21 CFR 886.4392
Device class
Class II
Review panel
Ophthalmic
Applicant
Phoenix Laser Systems, Inc. 205 25th Ave. N., St.Petersburg FL
Third party review
No

Clearances, product code LXS

Trailing 12 months

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

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