510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994362Substantially Equivalent

Headlamp Hl2000.

Angiolaz, Inc., Bellows Falls VT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994362 is the FDA 510(k) clearance record for HEADLAMP HL2000., a class II device, cleared for Angiolaz, Inc. on under FDA product code FSR (Light, Headband, Surgical). FDA records list 10 510(k) clearances for Angiolaz, Inc., from to . As of , FDA records show no recalls naming K994362.

Clearance record

Decision date
Received
(136 days to decision)
Product code
FSR Light, Headband, Surgical
Regulation
21 CFR 886.4335
Device class
Class II
Review panel
Ophthalmic
Applicant
Angiolaz, Inc. P.O. Box 556, Bellows Falls VT
510(k) summary
Statement
Third party review
No

Clearances, product code FSR

Trailing 12 months

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

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