OPTICAL BIOMETER

Primary DI
04573344510017
Brand
OPTICAL BIOMETER
Company
SANTEC CORPORATION
Model
ARGOS
Device description
ARGOS is a non-invasive, non-contact biometer based on swept-source optical coherence tomography (SS-OCT). The device is intended to acquire ocular measurements as well as perform calculations to determine the appropriate intraocular lens (IOL) power and type for implantation during intraocular lens placement. ARGOS measures the following 9 parameters: Axial Length, Corneal Thickness, Anterior Chamber Depth, Lens Thickness, K-values (Radii of flattest and steepest meridians), Astigmatism, Whiteto- white (corneal diameter) and Pupil Size. It is intended for use by ophthalmologists, physicians, and other eye-care professionals and may only be used under the supervision of a physician.
Published
2017-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MXKDevice,Analysis,Anterior Segment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MXKDevice, Analysis, Anterior SegmentOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150754000ARGOSSantec Corporation2015-10-02MXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04573344510017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04573344510017045733445100174573344510017

GMDN Terms#

Term, Definition table
TermDefinition
KeratometerA mains electricity (AC-powered) ophthalmic instrument designed to measure the curvature of the anterior surface of the cornea, particularly for determining the presence, extent, and axis of astigmatism (an error of refraction in the eye due to the cornea being unequally curved in different directions, so that rays of light in different meridians cannot be brought to focus together on the retina). It actually measures the radius of curvature in millimetres but typically displays it in dioptres. It is used mainly for contact lens fitting and for intraocular lens power determination prior to cataract surgery. This device is also known as an ophthalmometer.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
704295641
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04573344510024OPTICAL BIOMETERARGOS ver1.52019-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860003630624BOSSIntelon Optics, Inc.MXK2026-05-22
04049584034953Pentacam Cornea OCTOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2026-03-31
04571130283343AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIATOPCON CORPORATIONMXK2025-11-17
00380659984372WaveLightAlcon Laboratories, Inc.MXK2025-03-12
03664188000558ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
03664188000565ESSILORLUNEAU TECHNOLOGY OPERATIONSMXK2025-01-02
08034028770517ESSILORVISIA IMAGING SRLMXK2024-11-04
08034028770487MYAHVISIA IMAGING SRLMXK2023-10-12
03664188000060VisionixLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000404RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000923RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
03664188000930RODENSTOCKLUNEAU TECHNOLOGY OPERATIONSMXK2023-06-08
04059237000730HRT3Heidelberg Engineering GmbHMXK2023-03-03
08034028770463MYOPIA EXPERT 700VISIA IMAGING SRLMXK2022-06-22
08034028770456MYAHVISIA IMAGING SRLMXK2022-06-14
04049584025357Pentacam AXL WaveOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2021-11-03
04049584029942Myopia MasterOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2021-11-03
04049584029959Myopia MasterOCULUS Optikgeräte Gesellschaft mit beschränkter HaftungMXK2021-11-03
04059237000747TOMOCAPHeidelberg Engineering GmbHMXK2020-10-29
03664188000039VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2020-05-25
03664188000046VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2020-05-25
03664188000909VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2020-05-25
07640167751242GALILEISIS AG, Surgical Instrument SystemsMXK2019-09-20
04573344510024OPTICAL BIOMETERSANTEC CORPORATIONMXK2019-05-22
04059237000334HRT3 Heidelberg Engineering GmbHMXK2017-07-14
04059237000242SPECTRALIS, HRT3, HEPHeidelberg Engineering GmbHMXK2016-12-16
04059237000266HRT3Heidelberg Engineering GmbHMXK2016-09-24
04059237000273HRT3 Heidelberg Engineering GmbHMXK2016-09-24
03664188002200VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2016-09-23
03664188001203VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2016-09-23