510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K844364Substantially Equivalent

Skiascopic Racks

Luneau Laboratories, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K844364 is the FDA 510(k) clearance record for SKIASCOPIC RACKS, a class I device, cleared for Luneau Laboratories on under FDA product code HMH (Rack, Skiascopic). FDA records list 5 510(k) clearances for Luneau Laboratories, from to . As of , FDA records show no recalls naming K844364.

Clearance record

Decision date
Received
(50 days to decision)
Product code
HMH Rack, Skiascopic
Regulation
21 CFR 886.1750
Device class
Class I
Review panel
Ophthalmic
Applicant
Luneau Laboratories 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HMH

Trailing 12 months

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

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