510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930628Substantially Equivalent

Klaas IOL Lensfolder

Bova Intl., Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930628 is the FDA 510(k) clearance record for KLAAS IOL LENSFOLDER, a class I device, cleared for Bova Intl. on under FDA product code KYB (Lens, Guide, Intraocular). FDA records list 2 510(k) clearances for Bova Intl., from to . As of , FDA records show no recalls naming K930628.

Clearance record

Decision date
Received
(729 days to decision)
Product code
KYB Lens, Guide, Intraocular
Regulation
21 CFR 886.4300
Device class
Class I
Review panel
Ophthalmic
Applicant
Bova Intl. 2217 Sixth Ave., Fort Worth TX
510(k) summary
Statement
Third party review
No

Clearances, product code KYB

Trailing 12 months

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

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