510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864343Substantially Equivalent

Bl1 (Hard Contact Lens)

Beta Labs, Inc., Stoneham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864343 is the FDA 510(k) clearance record for BL1 (HARD CONTACT LENS), cleared for Beta Labs, Inc. on under FDA product code HPX (Lens, Contact (Polymethylmethacrylate)). FDA records list one 510(k) clearance for Beta Labs, Inc. As of , FDA records show no recalls naming K864343.

Clearance record

Decision date
Received
(24 days to decision)
Product code
HPX Lens, Contact (Polymethylmethacrylate)
Device class
Unclassified
Review panel
Unknown
Applicant
Beta Labs, Inc. 42 Pleasant St., Stoneham MA
Third party review
No

Clearances, product code HPX

Trailing 12 months

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

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