FDA.reportPublic FDA data

SPECTRALIS

Primary DI
04059237000075
Brand
SPECTRALIS
Company
Heidelberg Engineering GmbH
Model
SPEC-TSP
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MYCOphthalmoscope,Laser,Scanning
OBOTomography, Optical Coherence

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYCOphthalmoscope, Laser, ScanningOphthalmic2
OBOTomography, Optical CoherenceOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101223000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101223000SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FAHeidelberg Engineering2010-10-01OBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04059237000075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04059237000075040592370000754059237000075

GMDN Terms#

Term, Definition table
TermDefinition
Scanning-laser ophthalmic imaging systemAn assembly of mains electricity (AC-powered) ophthalmic instruments and digital image capturing/processing devices that uses a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for, e.g., assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329833875
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04059237000235SPECTRALIS86549865492025-03-24
04059237000723SPECTRALISS3610 [SN>20000]2024-10-04
04059237000792SPECTRALISS2610 [SN>20000] 2024-10-04
04059237001027SPECTRALIS Software V.7.2-US 2024-10-04
04059237001034SPECTRALISSoftware V.7.2-US with Heidelberg Eye Explorer2024-10-04
04059237000884SPECTRALISS10022022-10-26
04059237000891SPECTRALISS20022022-10-26
04059237000815SPECTRALISSoftware V7.0-US2022-02-02
04059237000839SPECTRALISSoftware with HEYEX 2 V7.0-US 2022-02-02
04059237000464SPECTRALISSoftware 6.13_US2020-01-21
04059237000488SPECTRALISSoftware with HEYEX 2 V6.14_US2020-01-21
04059237000716SPECTRALISSP-PWS-2001A [>20000]2019-10-29
04059237000570SPECTRALISSoftware 6.12_US2019-04-23
04059237000594SPECTRALISSoftware with HEYEX 2 V6.12_US2019-04-23
04059237000013SPECTRALISSPEC-CAM-S16002016-09-24
04059237000020SPECTRALISSPEC-CAM-S20002016-09-24
04059237000037SPECTRALISSPEC-CAM-S36002016-09-24
04059237000044SPECTRALISSP-PWS-1000A2016-09-24
04059237000051SPECTRALISSP-PWS-2000A2016-09-24
04059237000068SPECTRALISSP-PWS-2001A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053677040123EIDONCENTERVUE SPAMYC2026-04-29
08053677040130MAIACENTERVUE SPAMYC2026-04-29
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungOBO2026-03-31
045601262691023D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(Type:Maestro2)TOPCON CORPORATIONOBO2025-09-11
G744OCUB100OcuMet BeaconOcuSciences, Inc.MYC2025-06-25
04059237000235SPECTRALISHeidelberg Engineering GmbHMYC2025-03-24
04059237000235SPECTRALISHeidelberg Engineering GmbHOBO2025-03-24
04059237000952ANTERIONHeidelberg Engineering GmbHOBO2025-02-05
04059237000723SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237000723SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHOBO2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
00857691006039ENFOCUS 2300 INTEGRATED OCTBIOPTIGEN, INC.OBO2024-05-02
04059237000938ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
04059237000945ANTERIONHeidelberg Engineering GmbHOBO2023-11-18
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.MYC2023-06-12
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.OBO2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.MYC2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.OBO2023-06-12
04582273604704Cornea/Anterior Segment OCTTOMEY CORPORATION.OBO2023-06-07
04059237000884SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000884SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHOBO2022-10-26
04059237000877ANTERIONHeidelberg Engineering GmbHOBO2022-09-29
04059237000754ANTERIONHeidelberg Engineering GmbHOBO2022-02-14