FDA.reportPublic FDA data

MYAH

Primary DI
08034028770487
Brand
MYAH
Company
VISIA IMAGING SRL
Model
MYAH
Catalog number
42-0000983US
Published
2023-10-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered
MXKDevice, Analysis, Anterior Segment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2
MXKDevice, Analysis, Anterior SegmentOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222933000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222933000MYAHVisia Imaging S.R.L.2023-06-29MXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034028770487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034028770487080340287704878034028770487

GMDN Terms#

Term, Definition table
TermDefinition
Corneal topography systemAn assembly of ophthalmic devices used to measure the curvature and concentricity of the anterior corneal surface. It typically consists of a line-powered videokeratoscope using Placido imaging (involves disk with concentric white and black rings), and application software for installation in an included computer workstation, or external computer, for image processing and analysis. This device will be used to evaluate the need for refractive eye surgery, e.g., laser assisted in situ keratomileusis (LASIK) treatment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
447668039
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08034028770609TERA Dry Eye ImagerTERA Dry Eye Imager42-0002941US2025-08-06
08034028770524TOPCONSOLOS LITE42-00027702025-02-20
08034028770562TOPCONCC-100 HW6.03002002025-02-20
08034028770517ESSILORMYOPIA EXPERT 700BMT000042024-11-04
08034028770470SeeNASeeNASEENA0061002023-05-26
08034028770319TOPCONCC-1001205033002022-09-15
08034028770326TOPCONCC-100XP1205132002022-09-15
08034028770401TOPCONSOLOS42-00014172022-09-15
08034028770418TOPCONHENSON 9000HENSON90002022-09-15
08034028770463MYOPIA EXPERT 700MYOPIA EXPERT 700BMT000042022-06-22
08034028770456MYAHMYAH42-0000983US2022-06-14
08034028770364ALADDIN-M12402132020-09-09
08034028770180ALADDIN TMS124040012404002016-09-26
08034028770203ALADDIN HW3.0TEM1240212EXTEM1240212EX2016-11-03
08034028770333ALADDIN HW3.01240212US1240212US2016-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003630624BOSSIntelon Optics, Inc.MXK2026-05-22
10857253006085Phoenix ICON GO Control BoxPhoenix ClinicalHKI2026-05-14
00857253006019ICON HandpiecePhoenix ClinicalHKI2026-04-03
00857253006033FA ModulePhoenix ClinicalHKI2026-04-03
00857253006071DiffuserPhoenix ClinicalHKI2026-04-03
00857253006101Phoenix ICON with Training KitPhoenix ClinicalHKI2026-04-03
00857253006118Phoenix ICON & FA Module with Training KitPhoenix ClinicalHKI2026-04-03
00857253006132Phoenix ICON GO with Training KitPhoenix ClinicalHKI2026-04-03
00857253006149Phoenix ICON GO & FA Module with Training Kit Phoenix ClinicalHKI2026-04-03
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2026-03-31
05713315011597RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011641RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011924RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011931RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011948RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
05713315011962RetCam EnvisionNatus Medical Denmark ApSHKI2026-02-10
06430046261006Optomed Smartscope FAOptomed OyHKI2025-12-12
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONMXK2025-11-17
06430046260597Smartscope Pro full setOptomed OyHKI2025-11-13
06430046260689Smartscope Pro retinal setOptomed OyHKI2025-11-13
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONHKI2025-09-11
00860014304507OptainOptain Health, Inc.HKI2025-07-07
00860010658109Fundus PhotoFundus PhotoHKI2025-03-31
00380659984372WaveLightAlcon Laboratories, Inc.MXK2025-03-12
03664188000589ZEISSLUNEAU TECHNOLOGY OPERATIONSHKI2025-03-11
00860000249584Verily Numetric Retinal Camera VERILY LIFE SCIENCES LLCHKI2025-02-24
00852788008019NeolightNEOLIGHT LLCHKI2025-01-26
00852788008026NeolightNEOLIGHT LLCHKI2025-01-26
00852788008040NeolightNEOLIGHT LLCHKI2025-01-26
00852788008057NeolightNEOLIGHT LLCHKI2025-01-26