FDA Registration Active 🇺🇸 United States

WINSTON OPTICAL D/B/A WINSTON TECHNOLOGY SYSTEMS, CORP.

Reg #: 3002732585 · FEI: 3002732585 · Expires 2026
Products
2
Proprietary Names
2
Establishment Types
1
Classifications
2

Registration Details

Registration Name
WINSTON OPTICAL D/B/A WINSTON TECHNOLOGY SYSTEMS, CORP.
Registration Number
3002732585
FEI Number
3002732585
Status
Active
Expiry Year
2026
Initial Importer
Yes
Address
378 N. WOODLAND ST.
City
Englewood
State
NJ
ZIP
07631
Country
US

Regulatory Submissions

510(k) Number
K131208

Owner / Operator

Firm Name
WINSTON TECHNOLOGY SYSTEMS, CORP.
Operator Number
9047933
Address
378 N. WOODLAND STR, --
City
Englewood
State
NJ
Postal Code
07631
Country
US
Correspondent
VITALY - VELTSER

Products

Device Name Product Code
Lens, Contact, (Disposable) MVN
Lenses, Soft Contact, Daily Wear LPL

Proprietary Names

BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA Bausch + Lomb ULTRA for Astigmatism

Establishment Types

Complaint File Establishment per 21 CFR 820.198