FDA.reportPublic FDA data

MS-39

Primary DI
08056098473815
Brand
MS-39
Company
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
Model
103111
Device description
Non-contact medical device intended to perform the acquisition, visualization, analysis of the anterior segment of the eye and measurement of ocular biometry data, in order to support the diagnosis of ocular pathologies, trauma, and to support the routine surgery of the anterior segment
Published
2026-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K221601000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221601000MS-39C.S.O. S.R.L.2023-09-01OBO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056098473815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056098473815080560984738158056098473815

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic spectral-domain optical coherence tomography systemA mobile assembly of devices designed to use near infrared (NIR) LED light aimed into the eye to acquire, process, display and save in vivo depth-resolved images of anterior and posterior ocular tissue microstructures in clinical and perioperative examination through the use of interchangeable lenses. Spectral domain optical coherence tomography (SDOCT) is intended to aid in the diagnosis and evaluation of physiologic and pathologic conditions of the eye through non-contact optical imaging. Reflected light is picked up by a detector that converts it into electrical signals using a computer and dedicated software, providing cross-sectional or three-dimensional (3-D) volume scans for analysis.

Regulatory Flags#

DUNS number
432448470
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056098470012LUMENISSL 990 3X LUMENIS100226A302016-08-03
08056098470029ALCONSLIT LAMP SL 1000100209A502016-08-03
08056098470036LUMENISSL 990 5X LUMENIS100226A502016-09-30
08056098470043LUMENISSL 990 5X/Z LUMENIS100239A502016-09-30
08056098470128S4 OPTIKSL 9900 3X DIGITAL100257A30.D V02016-09-30
08056098470135S4 OPTIKSL 9900 3X 100257A30.J V02016-09-13
08056098470210S4 OPTIKSL 9800 3X LED + FILTER100258A30.J V02016-09-30
08056098470227S4 OPTIKSL 9800 5X LED DIGITAL100258A50.D V02016-09-30
08056098470258S4 OPTIKSL 990 5X ELITE100258A50.D V02016-09-30
08056098470265IRIDEXSL 9900 5X 100270A50.E V12016-09-30
08056098470272IRIDEXSL 9800 5X 1002072A50.E V12016-09-30
08056098470647S4 OPTIKSL 990 5X 100250A50.J V02016-09-13
08056098470654IRIDEXSL 980 5X 100213A50.E V12016-09-30
08056098470159S4 OPTIKSL 990 5X LED digital100257A50.D V02020-12-10
08056098470166S4 OPTIKSL 990 25X LED 100257A50.R V02020-12-10
08056098470197S4 OPTIKSL 9800 2X LED 100258A20.R V02020-12-10
08056098470234S4 OPTIKSL 9800 5X LED 100258A50.J V02020-12-10
08056098470678S4 OPTIKSL 9800 zoom100258AZ0.J V02020-12-10
08056098470708S4 OPTIKSL 990 2X LED 100257A20.R V02020-12-10
08056098470753S4 OPTIKSL 9800 2X100272A20.R V02020-12-10

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
04573344510017OPTICAL BIOMETER SANTEC CORPORATIONMXK2017-05-01
04059237000242SPECTRALIS, HRT3, HEPHeidelberg Engineering GmbHMXK2016-12-16
04059237000266HRT3Heidelberg Engineering GmbHMXK2016-09-24
04059237000273HRT3 Heidelberg Engineering GmbHMXK2016-09-24
03664188002200VISIONIXLUNEAU TECHNOLOGY OPERATIONSMXK2016-09-23