FDA.reportPublic FDA data

S4 OPTIK

Primary DI
08056098470258
Brand
S4 OPTIK
Company
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
Model
SL 990 5X ELITE
Catalog number
100258A50.D V0
Device description
SLIT LAMP SL990 ELITE
Published
2016-09-30
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
08056098470258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056098470258080560984702588056098470258

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic slit lamp, examinationAn electrically-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
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
08056098470760S4 OPTIKSL 9800 3X100272A30.J V02020-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0695109080097866VT66 VISION TECH CO., LTD.HJO2026-04-27
04250668607202VISUREF 600Carl Zeiss Vision GmbHHJO2026-04-24
04049471097153SL 220Carl Zeiss Meditec AGHJO2026-01-13
00852194002137SL-5000Hightech American Industrial Labs IncHJO2025-12-18
04547451338321INAMIINAMI & CO., LTD.HJO2025-08-29
00819034023240TalarLiftFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520738PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520745PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520752PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520769PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520776PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520783PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520790PolyLock Small BoneFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520806IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520813IntraLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520820LapiLockFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520837DynaBridgeFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520844DynaBridgeFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520851Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520868Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520875LSI Arthroereisis PegFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520882Sgarlato SilasticFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520905PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520912PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520929PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00840124520936PolyLock AnkleFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007346Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
00852164007353Hammer TechFUSION ORTHOPEDICS, LLCHJO2025-05-19
04987646810476KOWA SL-19KOWA COMPANY,LTD.HJO2024-10-08
04560323640940MARCOTAKAGI SEIKO CO.,LTD.HJO2024-03-14