FDA.reportPublic FDA data

iStand

Primary DI
00858848006285
Brand
iStand
Company
OPTOVUE, INC.
Model
iStand
Catalog number
700-48491-001
Device description
iStand 2
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HLIOphthalmoscope, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HLIOphthalmoscope, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103266000ISTANDOptovue, Inc.2011-06-03HLI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858848006285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858848006285008588480062858588480062850858848006285

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic stand, electricA mains electricity (AC-powered) device designed as a column or post, usually with a small flat surface top, used to provide support and position control for ophthalmic devices commonly used during an ophthalmic examination/treatment (e.g., a slit lamp, keratometer, refractometer). It typically has a powered height adjustment function enabling the clinician to align (raise/lower) the ophthalmic instruments to the eye level of the patient. It is typically stationary and may have drawers, shelves, and built-in outlets to supply low-voltage electricity to the instruments.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-941-9240service@optovue.com

Regulatory Flags#

DUNS number
196500461
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858848006759iVueiVue 100700-54520-0012020-08-24
00858848006766iFusioniFusion700-54542-0012020-08-24
00858848006773iVueiVue 100700-54543-0012020-08-24
00858848006780iCamiCam100700-54524-0012020-08-24
00858848006735iScaniVue 500700-52800-0022020-02-13
00858848006742iScaniVue 500700-52801-0022020-02-13
00858848006728RTVue XR Avanti100700-54345-0012020-02-03
00858848006704RTVue XR Avanti100700-51134-0052019-09-20
00858848006667RTVue XR Avanti ScannerAvanti Scanner500-50845-0032019-06-12
00858848006674RTVue XR Avanti100700-51134-0042019-06-12
00858848006001AvantiRTVue XR100-1700-48076-0042016-08-31
00858848006018iScaniVue 500700-49428-0032016-08-31
00858848006025AvantiRTVue XR100-2700-48098-0042016-08-31
00858848006032AvantiRTVue XR Scanner500-47760-0052016-08-31
00858848006049iVueiVue 100-1700-47817-0042016-08-31
00858848006056iVueiVue 100-1700-47818-0042016-08-31
00858848006063iVueiVue 100700-47826-0052016-08-31
00858848006070iVueiVue 100700-47827-0052016-08-31
00858848006087iVueiVue 100700-48355-0052016-08-31
00858848006094iVueiVue 100-2700-48577-0042016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945095544135zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544197zumaxZumax Medical Co., LTDHLI2026-05-20
06945095544500zumaxZumax Medical Co., LTDHLI2026-05-20
06942576062461RobotrakRobotrak Technologies Co., LtdHLI2026-04-30
00697077003081Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2025-07-14
04549292147216CANON INC.CANON INC.HLI2025-05-02
00697077003050Amico Diagnostic, Inc.Amico Diagnostic IncorporatedHLI2024-09-18
00697077003043Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2024-07-11
00697077003029Amico Diagnostic StationAmico Diagnostic IncorporatedHLI2024-05-02
00732094086515Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094087727Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00732094089202Welch Allyn, Inc.WELCH ALLYN, INC.HLI2023-08-17
00697077002237Amico Diagnostic WallboardAmico Diagnostic IncorporatedHLI2023-07-27
04053755119660INDIRECT OPHTHALMOSCOPE BINOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755120307INDIRECT OPHTHALMOSCOPE MONOCULARHeine Optotechnik GmbH & Co. KGHLI2022-12-15
04053755153541OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755153695OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181704OMEGA 500Heine Optotechnik GmbH & Co. KGHLI2022-12-12
04053755181711OMEGA 500 LEDHeine Optotechnik GmbH & Co. KGHLI2022-12-12
00732094346930Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346947Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346954Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346961Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094347555Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-08
00732094346978Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346985Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094346992Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347005Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347012Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05
00732094347029Welch Allyn, Inc.WELCH ALLYN, INC.HLI2022-08-05