Novanew Reconditioning System for Prof. Use in-Office Use Only
by Novavision, Inc. 510(k)
Active
510(k) K960584
Overview
The Novavision Novanew Reconditioning System for Professional Use In-office Use Only is a device indicated for the in-office re-hydrophilization of rigid gas permeable contact lenses. It is specifically designed for use with NOVAWET, PERCEPTION and VANGUARD rigid gas permeable contact lenses for daily wear.
The system is supplied for professional in-office use only and is not intended for patient self-use. It is a reusable system used by eye care professionals to recondition contact lenses. The device received FDA 510(k) clearance (K960584) and is classified as a Class II medical device under product code HQD, with regulatory oversight under 21 CFR 886.5916.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK960584 | Date15 Aug 1996 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HQD
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.5916
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Other devices from Novavision, Inc.
Questions
What is the Novanew Reconditioning System used for?
The Novanew Reconditioning System is indicated for the in-office re-hydrophilization of rigid gas permeable contact lenses. It restores lens wettability to improve comfort and wearability for daily wear lenses such as NOVAWET, PERCEPTION and VANGUARD models.
Who is authorized to use the Novanew Reconditioning System?
The system is supplied for professional in-office use only and is not intended for patient self-use. It is designed to be used by eye care professionals in a clinical setting to recondition contact lenses.
Is the Novanew Reconditioning System reusable or single-use?
The Novanew Reconditioning System is a reusable system. Eye care professionals can use it multiple times to recondition rigid gas permeable contact lenses, following proper cleaning and maintenance procedures as outlined in the labeling.
Which contact lenses is the Novanew System compatible with?
The Novanew Reconditioning System is specifically designed for use with NOVAWET, PERCEPTION and VANGUARD rigid gas permeable contact lenses intended for daily wear. It is not indicated for use with other lens types or brands.
What regulatory pathway was used for the Novanew Reconditioning System?
The device received FDA 510(k) clearance under submission K960584 and is classified as a Class II medical device under product code HQD. It is regulated under 21 CFR 886.5916 for ophthalmic devices.