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
K994340Substantially Equivalent

Clinical Specular Microscope, Model Hai Cl-1000Xyz

Hai Laboratories, Inc., Sound Beach NY / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K994340 is the FDA 510(k) clearance record for CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ, a class II device, cleared for Hai Laboratories, Inc. on under FDA product code HLI (Ophthalmoscope, Ac-Powered). FDA records list one 510(k) clearance for Hai Laboratories, Inc. As of , FDA records show no recalls naming K994340.

Clearance record

Decision date
Received
(272 days to decision)
Product code
HLI Ophthalmoscope, Ac-Powered
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Hai Laboratories, Inc. 30 Northpoint Rd., Sound Beach NY
510(k) summary
Statement
Third party review
No

Clearances, product code HLI

Trailing 12 months

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

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