Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2184002

FEI Number

1000115753

Entity Name

LIFECORE BIOMEDICAL LLC

City/State/Country

CHASKA, MN, US

Establishment Address

3515 LYMAN BLVD., CHASKA, MN 55318, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

LIFECORE BIOMEDICAL, LLC (Owner Number: 2183682)

Owner / Operator Contact Address

3515 LYMAN BLVD., --, Chaska, MN 55318, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Viscoat, DuoVisc, DiscoVisc Totalvisc Stablevisc Healon Endocoat Euflexxa ProVisc

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2017-11-03
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2023-04-18
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2012-07-03
MOZ	Acid, Hyaluronic, Intraarticular	Unknown	Class 3	N/A	2018-01-10
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2017-11-03
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2021-05-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LIFECORE BIOMEDICAL, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0530-2015	Abbott Medical Optics Inc (AMO)	3	Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging and Cannula Product of USA Abbott Healon Duet Dual Pack 0.55 ml OVD 0.85 ml Healon EndoCoat OVD Contents: -one sterile syringe of Healon Ophthalmic Viscosurgical Device (OVD) 0.55 ml (10 mg/ml Sodium Hyaluronate) -one sterile syringe of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD) 0.85 ml (30 mg/ml Sodium Hyaluronate) Part Number: US: VT585U and 57502000 (packaged in Healon Duet 10290080) OUS: VT585 and 57550500 (packaged in Healon duet 10220010, 10220011 and 10220012)
Z-2062-2017	Abbott Medical Optics Inc. (AMO)	3	Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, 10213012, 10223012, 10290701, 10294751, 10295701
Z-2063-2017	Abbott Medical Optics Inc. (AMO)	3	Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014
Z-2064-2017	Abbott Medical Optics Inc. (AMO)	3	Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012
Z-2065-2017	Abbott Medical Optics Inc. (AMO)	3	Healon 5 Pro, Part No. 10270015

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2184002. Last updated year: 2026. Please use registration number 2184002 when referencing this establishment in official correspondence.