510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883270Substantially Equivalent

Iris Nd:yag Opthalmic Laser

California Laboratories, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883270 is the FDA 510(k) clearance record for IRIS ND:YAG OPTHALMIC LASER, a class II device, cleared for California Laboratories, Inc. on under FDA product code LQJ (Lens, Surgical, Laser, Accesssory, Ophthalmic Laser). FDA records list 4 510(k) clearances for California Laboratories, Inc., from to . As of , FDA records show no recalls naming K883270.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LQJ Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
Regulation
21 CFR 886.4390
Device class
Class II
Review panel
Ophthalmic
Applicant
California Laboratories, Inc. 2270-M Camino Vida Roble, Carlsbad CA
Third party review
No

Clearances, product code LQJ

Trailing 12 months

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

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