# K960584: Novanew Reconditioning System for Prof. Use in-Office Use Only

- Pathway: 510(k) (Traditional)
- Applicant: Novavision, Inc.
- Decided: Aug 15, 1996 after 185 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Nova-New Lens Re-hydrophilization System is indicated for use for the in-office only re-hydrophilization of the NOVAWET, PERCEPTION and VANGUARD rigid gas permeable contact lenses for daily wear, The Nova-New Leas Re-hydrophilization System is indicated when the practitioner, at his discretion, determines that he wishes to modify the surface of the contact lens.

Source page: https://510kreport.com/device/K960584
Methodology: https://510kreport.com/methodology