FDA.reportPublic FDA data

iZoom Loupes

Primary DI
00860179001099
Brand
iZoom Loupes
Company
Dentlight Inc.
Model
8500051
Catalog number
8500051
Device description
iZoom Magnification Loupes
Published
2021-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSPLoupe, Diagnostic/Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSPLoupe, Diagnostic/SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860179001099PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860179001099008601790010998601790010990860179001099

GMDN Terms#

Term, Definition table
TermDefinition
LoupeA convex lens with an built-in, electrical light source used for magnifying vision and concentrating the light upon an object or objects being viewed. It can be used for a variety of purposes, e.g., the examination of an object for laboratory work, diagnosis, minor surgery, dermatology, or by persons with a strong eyesight impairment. The loupe is typically mounted on the end of an adjustable arm (e.g., a flexible tube or an articulating arm) which is attached to a stable base or clamped to a surface worktop.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007636901sales1@dentlight.com

Regulatory Flags#

DUNS number
171208585
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860179001013FUSION PBM Plus Light792008079200802026-05-27
00860179001020Nano Freedom Headlight860011586001152021-08-09
00860179001044Ultrafast Diode Laser730010073001002022-01-24
00860179001006FUSION Curing Light780008078000802021-08-09
00860179001037FUSION Plus Curing Light782008078200802021-08-09
00860179001068FUSION Grand Curing Light783008078300802021-08-09
00860179001075FUSION-DOE Light System770051277005122021-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06941877825287EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825294EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825300EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825317EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825324EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-05-06
06941877825096EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825102EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825119EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825126EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825133EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825140EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825157EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825164EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825171EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825188EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825195EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825201EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825218EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825225EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825232EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825249EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825256EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825263EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
06941877825270EighteethChangzhou Sifary Medical Technology Co., Ltd.FSP2026-04-30
00850036373377Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373384Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373391Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373407Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373414Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05
00850036373421Luxe™ 2.5 Semi-custom loupeMETREX RESEARCH, LLCFSP2026-02-05