510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K241229Substantially Equivalent

Hello,eyes® BIO Plug

Bio Optics Co., Ltd., Seongnam-Si, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241229 is the FDA 510(k) clearance record for Hello,eyes® BIO Plug, cleared for Bio Optics Co., Ltd. on under FDA product code LZU (Plug, Punctum). FDA records list one 510(k) clearance for Bio Optics Co., Ltd. As of , FDA records show no recalls naming K241229.

Clearance record

Decision date
Received
(57 days to decision)
Product code
LZU Plug, Punctum
Device class
Unclassified
Review panel
Unknown
Applicant
Bio Optics Co., Ltd. A-1215, Skv1 Tower, 14, Galmachi-Ro 288beon-Gil, Jungwon-Gu, Seongnam-Si, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LZU

Trailing 12 months

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

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