510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945443Substantially Equivalent

Bobes Lens Set

Bobes S.A., Madrid, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945443 is the FDA 510(k) clearance record for BOBES LENS SET, a class I device, cleared for Bobes S.A. on under FDA product code HPC (Set, Lens, Trial, Ophthalmic). FDA records list 3 510(k) clearances for Bobes S.A., from to . As of , FDA records show no recalls naming K945443.

Clearance record

Decision date
Received
(254 days to decision)
Product code
HPC Set, Lens, Trial, Ophthalmic
Regulation
21 CFR 886.1405
Device class
Class I
Review panel
Ophthalmic
Applicant
Bobes S.A. Ctra. Fuente Del Toro, S/N, Madrid, ES
510(k) summary
Statement
Third party review
No

Clearances, product code HPC

Trailing 12 months

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

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