Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014656174

FEI Number

3014656174

Entity Name

ZOOMAX (USA) INC.

City/State/Country

Boston, MA, US

Establishment Address

6 Liberty Square #2572, Boston, MA 02109, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Zoomax (USA) Inc. (Owner Number: 10058885)

Owner / Operator Contact Address

6 Liberty Square #2572, Boston, MA 02109, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Acesight Acesight S Acesight VR M5 HD Plus Butterfly Snow 7 HD Plus Snow 4.3 Snow 10 Pro Luna S Snow 12 Luna 8 Luna 6

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HOI	Spectacle, Magnifying	Ophthalmic	Class 1	886.5840	2018-11-06
HJF	Magnifier, Hand-Held, Low-Vision	Ophthalmic	Class 1	886.5540	2018-11-06

Official Correspondent

Stella Shen

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zoomax (USA) Inc.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014656174. Last updated year: 2026. Please use registration number 3014656174 when referencing this establishment in official correspondence.