FDA.reportPublic FDA data

S4 OPTIK

Primary DI
08056098470814
Brand
S4 OPTIK
Company
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
Model
SL 9900 3X LED digital
Catalog number
100270A30.D V0
Device description
SLIT LAMP SL9900 3X digital
Published
2020-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HJOBiomicroscope, Slit-Lamp, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992836000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992836000SL990, SL980, SL950Cso1999-11-09HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056098470814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056098470814080560984708148056098470814

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationA mains electricity (AC-powered), ophthalmic, binocular microscope designed to examine the interior anatomy of the eye (anterior and posterior surfaces) by viewing through the iris. It produces a narrow slit of powerful light which is projected into the eye, and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular surfaces. It is used to perform a variety of measurements [e.g., intraocular pressure (IOP) or tonometry, corneal thickness, anterior chamber depth] and to evaluate symptoms (e.g., eye itchiness, grittiness, pain, dry eyes, photophobia, and reduced visual acuity).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
432448470
Device count
1
Serial number
true
Manufacturing date on label
true

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

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