510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000544Substantially Equivalent

Boucher Degroot Head Positioning Glasses, Model 8080

Labtician Ophthalmics, Inc., Oakville, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000544 is the FDA 510(k) clearance record for BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080, a class I device, cleared for Labtician Ophthalmics, Inc. on under FDA product code HJX (Reader, Prism, Ophthalmic). FDA records list 3 510(k) clearances for Labtician Ophthalmics, Inc., from to . As of , FDA records show no recalls naming K000544.

Clearance record

Decision date
Received
(20 days to decision)
Product code
HJX Reader, Prism, Ophthalmic
Regulation
21 CFR 886.5810
Device class
Class I
Review panel
Ophthalmic
Applicant
Labtician Ophthalmics, Inc. 2140 Winston Park Dr., Unit 6, Oakville, Ontario, CA
510(k) summary
Statement
Third party review
No

Clearances, product code HJX

Trailing 12 months

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

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