FDA.reportPublic FDA data

Reticapture

Primary DI
08800016904055
Brand
Reticapture
Company
CLASSYS Inc.
Model
DNC-C1
Published
2024-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HKICamera, Ophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKICamera, Ophthalmic, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173474000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173474000RetiCaptureIlooda Co,., Ltd.2018-07-27HKI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800023201017PreviousGS10
08800016904055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800023201017088000232010178800023201017
08800016904055088000169040558800016904055

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic fundus cameraAn electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689842183
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800016904925Reepot Set PackageVSLS2024-10-30
08800016904932Reepot Main UnitVSLS2024-10-30
08800016904949Reepot HandpieceVSLS2024-10-30
08800016903140Max-25MAX-252025-07-02
08800016903171Max-M25MAX-M252025-07-02
08800016903423Max-25CMAX-25C2025-07-02
08800016903447Max-64CMAX-64C2025-07-02
08800016903454Max-M25CMAX-M25C2025-07-02
08800016904246MTR-AC-01MTR-AC-012025-07-02
08800016904253MTR-AC-04MTR-AC-042025-07-02
08800016904291MTR-AC-27GMTR-AC-27G2025-07-02
08800016905045QUADESSY Set PackageQD1-M4002025-07-02
08800016905052QUADESSY Main UnitQD1-M4002025-07-02
08800016905069QUADESSY Deeplus hand pieceQD1-M4002025-07-02
08800016905076QUADESSY Smartcure(Basic) hand pieceQD1-M4002025-07-02
08800016905083Wav12WAV122025-07-02
08800016905090Wav30WAV302025-07-02
08800016905106Wav50WAV502025-07-02
08800016905175QUADESSY Wavplus hand pieceQD1-M4002025-07-02
08800016905182QUADESSY Neutral hand pieceQD1-M4002025-07-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
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
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
00852788008064NeolightNEOLIGHT LLCHKI2025-01-26
00852788008071NeolightNEOLIGHT LLCHKI2025-01-26
10852788008085NeolightNEOLIGHT LLCHKI2025-01-26
20852788008020NeolightNEOLIGHT LLCHKI2025-01-26