LZP · Aid, Surgical, Viscoelastic
Ophthalmic · 21 CFR 886.4275 · Class 3
Overview
| Product Code | LZP |
|---|---|
| Device Name | Aid, Surgical, Viscoelastic |
| Regulation | 21 CFR 886.4275 |
| Device Class | Class 3 |
| Review Panel | Ophthalmic |
Identification
An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
Classification Rationale
Class III.
Cleared Devices (13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P220009 | StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD) | Bausch Health Companies, Inc. | Feb 22, 2023 | APPR |
| P200025 | ClearVisc Ophthalmic Viscosurgical Device (OVD) | Bausch Health | Mar 23, 2021 | APPR |
| P110007 | HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE) | Johnson & Johnson Surgical Vision, Inc. | Jul 2, 2012 | APPR |
| P000046 | STAARVISC II | Anika Therapeutics, Inc. | Apr 18, 2001 | APPR |
| P990023 | CELLUGEL(R) OPHTHALMIC VISCOSURGICAL DEVICE | Alcon Laboratories | Feb 24, 2000 | APPR |
| P960011 | BIOLON 1% SODIUM HYALURONATE VISCOELASTIC SURGICAL AID FLUID | Altacor , Ltd. | Jul 16, 1998 | APPR |
| P890047 | PROVISC(TM)VISCOELASTIC PREPARATION | Alcon Research, Ltd. | Sep 26, 1991 | APPR |
| P880031 | VITRAX SODIUM HYALURONATE | Abbott Medical Optics, Inc. | Aug 10, 1989 | APWD |
| P860047 | HYDROXYPROPYLMETHYLCELLULOSE 20MG/ML | Bausch & Lomb, Inc. | Jul 12, 1988 | APPR |
| P820079 | CDS II (SODIUM CHONDROITIN SULFATE) | Alcon Laboratories | Sep 30, 1986 | APWD |
| P840064 | VISCOAT(TM)/DVOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICES | Alcon Laboratories | Apr 30, 1986 | APPR |
| P810025 | AMVISC(R) | Bausch & Lomb, Inc. | Oct 18, 1983 | APPR |
| P810031 | HEALON, HEALON GV, HEALON5 PRODUCTS SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES | Johnson & Johnson Surgical Vision, Inc. | Jan 14, 1983 | APPR |
Top Applicants
- Alcon Laboratories — 3 clearances
- Johnson & Johnson Surgical Vision, Inc. — 2 clearances
- Bausch & Lomb, Inc. — 2 clearances
- Bausch Health Companies, Inc. — 1 clearance
- Bausch Health — 1 clearance
