510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K021843Substantially Equivalent

Eyefeel Ophthalmic Warmer

Bio-Lipid, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021843 is the FDA 510(k) clearance record for EYEFEEL OPHTHALMIC WARMER, a class I device, cleared for Bio-Lipid, Inc. on under FDA product code IMD (Pack, Hot Or Cold, Disposable). FDA records list 2 510(k) clearances for Bio-Lipid, Inc., from to . As of , FDA records show no recalls naming K021843.

Clearance record

Decision date
Received
(90 days to decision)
Product code
IMD Pack, Hot Or Cold, Disposable
Regulation
21 CFR 890.5710
Device class
Class I
Review panel
Physical Medicine
Applicant
Bio-Lipid, Inc. 1301 K St., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IMD

Trailing 12 months

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

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