510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944156Substantially Equivalent

Heine Lambda 100

Heine USA, Ltd., Cary NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944156 is the FDA 510(k) clearance record for HEINE LAMBDA 100, a class I device, cleared for Heine USA , Ltd. on under FDA product code HOX (Chart, Visual Acuity). FDA records list one 510(k) clearance for Heine USA , Ltd. As of , FDA records show no recalls naming K944156.

Clearance record

Decision date
Received
(139 days to decision)
Product code
HOX Chart, Visual Acuity
Regulation
21 CFR 886.1150
Device class
Class I
Review panel
Ophthalmic
Applicant
Heine USA , Ltd. 3500 Regency Pkwy. Suite"C", Cary NC
510(k) summary
Statement
Third party review
No

Clearances, product code HOX

Trailing 12 months

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

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