510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892058Substantially Equivalent

Isl Qc 2000

Intelligent Surgical Lasers, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892058 is the FDA 510(k) clearance record for ISL QC 2000, a class II device, cleared for Intelligent Surgical Lasers, Inc. on under FDA product code LXS (Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla). FDA records list 2 510(k) clearances for Intelligent Surgical Lasers, Inc., from to . As of , FDA records show no recalls naming K892058.

Clearance record

Decision date
Received
(78 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
Intelligent Surgical Lasers, Inc. P.O. Box 85608, San Diego CA
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