Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2248180

FEI Number

1000307813

Entity Name

CHARMANT U.S.A.

City/State/Country

Morris Plains, NJ, US

Establishment Address

400 AMERICAN RD., Morris Plains, NJ 07950, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

CHARMANT, INC. (Owner Number: 9001784)

Owner / Operator Contact Address

6-5 KAWASARI-CHO, --, SABAE-CITY, FUKUI-PREF, JP-NOTA 916, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Charmant Charmant Charmant Charmant Charmant Charmant Charmant Charmant Charmant Charmant Fukushima Charmant ARISTAR Eddie Bauer Isaac Mizrahi Minamoto Esprit Aristar Charmant Titanium Line Art Z-Titanium Elle Ad-Lib Elle Eddie Bauer Isaac Mizrahi Esprit Charmant Charmant Charmant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2018-04-02
GZX	Instrument, Microsurgical	Neurology	Class 1	882.4525	2015-02-16
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-04-28
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2019-05-28
HNH	Ring, Ophthalmic (Flieringa)	Ophthalmic	Class 1	886.4350	2012-08-17
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-06-25
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-08-28
HND	Spatula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-08-17
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2014-09-24
HNC	Specula, Ophthalmic	Ophthalmic	Class 1	886.4350	2012-06-06
HNQ	Hook, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-08-18
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2012-08-10
HQZ	Frame, Spectacle	Ophthalmic	Class 1	886.5842	1999-09-03
HQY	Sunglasses (Non-Prescription Including Photosensitive)	Ophthalmic	Class 1	886.5850	1999-09-03
HNF	Scissors, Ophthalmic	Ophthalmic	Class 1	886.4350	2011-08-18
HOH	Spectacle, Operating (Loupe), Ophthalmic	Ophthalmic	Class 1	886.4770	2021-07-16
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2018-12-17

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CHARMANT, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8043467	CHARMANT, INC.	SABAE-CITY, FUKUI-PREF., JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K910951	United Optical, Spa	OPTHLAMIC FRAMES	1991-05-06
K940726	Jay-Y Enterprises Co., Inc.	NONE-GENERIC	1994-04-11
K934837	Simon Marketing, Inc.	SUNGLASSES	1993-12-08
K852902	Yours Enterprise Co., Ltd.	METALLIC SUNGLASSES	1985-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-04	Surgical Specialties Corp	1	Sharpoint 2.75 mm x 3.75 mm ClearTrap Trapezoid Knife Clear Corneal Implant Angled. The product can be sold as an individual unit or in a box of 6 knives.
Z-1922-2024	Alcon Research LLC Aspex Facility	1	20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Z-1923-2024	Alcon Research LLC Aspex Facility	1	ClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1924-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Z-1925-2024	Alcon Research LLC Aspex Facility	1	ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A

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1043534	WRIGHT MEDICAL TECHNOLOGY, INC.	Arlington, TN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2248180. Last updated year: 2026. Please use registration number 2248180 when referencing this establishment in official correspondence.