510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800238Substantially Equivalent

Moire Fringe Visometer After Lotmar

Hagg-Streit Service, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800238 is the FDA 510(k) clearance record for MOIRE FRINGE VISOMETER AFTER LOTMAR, a class II device, cleared for Hagg-Streit Service, Inc. on under FDA product code HKL (Retinoscope, Ac-Powered). FDA records list 2 510(k) clearances for Hagg-Streit Service, Inc., from to . As of , FDA records show no recalls naming K800238.

Clearance record

Decision date
Received
(34 days to decision)
Product code
HKL Retinoscope, Ac-Powered
Regulation
21 CFR 886.1780
Device class
Class II
Review panel
Ophthalmic
Applicant
Hagg-Streit Service, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HKL

Trailing 12 months

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

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