# K984383: Ultracare Neutralizing Tablets

- Pathway: 510(k) (Special)
- Applicant: Allergan, Inc.
- Decided: Dec 18, 1998 after 10 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P850088/S036 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P850088/S036: Ultra Care (TM) Neutralizing Tablet, Advanced Medical Optics, Inc. (1997). A supplement to the PMA, as the summary prints it.

## Indications for use
ULTRACARE Neutralizing Tablets are part of the ULTRACARE System, a disinfecting, neutralizing and storage system for daily and extended wear soft (hydrophilic) contact lenses in a chemical (not heat) lens care system. The ULTRACARE Neutralizing Tablets are indicated for use to neutralize the ULTRACARE Disinfecting Solution in the ULTRACARE System. ULTRACARE Neutralizing Tablets are added at the beginning of the disinfection cycle so that disinfection and neutralization occur without any additional steps.

Source page: https://510kreport.com/device/K984383
Methodology: https://510kreport.com/methodology