FDA.reportPublic FDA data

Essilor

Primary DI
06945087565018
Brand
Essilor
Company
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO.,LTD.
Model
SL650
Device description
Slit Lamp Microscopes are intended to observe the disease of the anterior structures and tissue damage of eyes.
Published
2022-11-02
Public version status
Update
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
HJOBiomicroscope, Slit-Lamp, Ac-Powered

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152429000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152429000Slit Lamp MicroscopeShanghai Mediworks Precision Instruments Co. , Ltd.2016-05-11HJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945087565018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945087565018069450875650186945087565018

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic examination slit lampAn electrically-powered, ophthalmic, binocular microscope designed to examine the interior anatomy of the eye by viewing through the pupil; it is not dedicated to surgical procedures. It projects a narrow slit of light into the eye and resulting light reflections are detected obliquely with a travelling microscope to enable observation of the internal ocular structures. 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Regulatory Flags#

DUNS number
527884077
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
06945087500057EssilorSL650+2022-11-02
06945087520000RodenstockRSL 21002021-05-17
06945087525005RodenstockRSL 26002021-05-17
06945087525012RodenstockRSL 2600digital2021-05-17
06945087590003TomeyTSL-900Z2021-05-17
06945087590010TomeyTSL-900H2021-05-17
06945087590027TomeyTSL-900Hdigital2021-05-17
06945087540015EssilorSL400H2021-05-10
06945087540022EssilorSL400L2021-05-10
06945087545010EssilorSL450H2021-05-10
06945087545027EssilorSL450L2021-05-10
06945087505175MediworksScansys TA5172020-03-12
06945087516225MediworksFC1622021-05-18
06945087500026MediworksSM6212022-11-02
06945087500040MediWorksS2902022-11-02
06945087500217MediWorksSL6502022-11-02
06945087515013MediworksS1502022-11-02
06945087530023MediworksSL300L2021-05-10
06945087535066MediworksSL350H2021-05-10
06945087535073MediworksSL350L2021-05-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04562123289602SLIT LAMP SL-D4 (Type:LED)TOPCON CORPORATIONHJO2026-09-28
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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
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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