# K082087: Eyefeel Ophthalmic Warmer

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Lipid, Inc.
- Decided: Sep 11, 2008 after 50 days
- Product code: IMD (Pack, Hot Or Cold, Disposable)
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K970399 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021843: Eyefeel Ophthalmic Warmer, Bio-Lipid, Inc. (2002). Our reading of the summary gave K021834, FDA’s number for Suture Fixation Device; Mesh Fixation Device (Mle, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “EyeFeel Ophthalmic Warmer”.

## Indications for use
The EyeFeel ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia. The EyeFeel Ophthalmic Warmer also may relieve accommodative fatigue and may help recover baseline visual acuity levels after prolonged work on visual display terminals.

Source page: https://510kreport.com/device/K082087
Methodology: https://510kreport.com/methodology