# K032481: Theratears Contact Lens Comfort Drops

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Vision Research, Inc.
- Decided: Nov 4, 2003 after 84 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: 2 generations back to P910075/S007 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992028: Refresh Contacts Lubricating and Rewetting Drops, Allergan, Inc. (1999). Our reading of the summary gave K992928, FDA’s number for CD Horizon Spinal System (Sofamor Danek USA,Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Allergan Refresh Contacts”.
- K013204: Aquify Lens Comfort Drops, Ciba Vision Corporation (2002) Summary page 1.

## Indications for use
TheraTears Contact Lens Comfort Drops is indicated to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) contact lenses, to help relieve dryness, discomfort and irn'tation that may be associated with lens wear and, to cushion lenses and ease insertion. RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.

Source page: https://510kreport.com/device/K032481
Methodology: https://510kreport.com/methodology