FDA.reportPublic FDA data

LABOMED SLx 40- 3 Step Slit lamp -LED

Primary DI
08908006463510
Brand
LABOMED SLx 40- 3 Step Slit lamp -LED
Company
LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Model
8126401
Published
2023-06-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
PUEBiomicroscope, Slit-Lamp, Ac-Powered, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUEBiomicroscope, Slit-Lamp, Ac-Powered, ExemptOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08908006463510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08908006463510089080064635108908006463510

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
919049606
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08906168451536Prima Swift surgical Microscope61825052026-07-19
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)81263002023-06-17
08906168451499Prima Lite Surgical Microscope61815012026-07-19
08906168451505Prima Lite Surgical Microscope Wall mount61815022026-07-19
08906168451512Prima Lite ENT Surgical Microscopes61825042026-07-19
08906168451529Prima Lite trainer61825122026-07-19
08906168451543Prima Pro surgical Microscope61836012026-07-19
08906168451550Prima Pro surgical Microscope61836032026-07-19
08906168451567Prima Floor Stand with Column6182001-8712026-07-19
08908006463022Labomed Prima DNT Microscope Mobile Mount61380002022-12-12
08908006463046Labomed Prima DNT Microscope Wall mount61371012022-12-13
08908006463053Labomed Prima DNT Microscope Ceiling Mount61372012022-12-13
08908006463060Labomed Prima DNT Microscope Table Mount61675002022-12-13
08908006463077Labomed Prima DNT Microscope Wall mount long arm61371022022-12-13
08908006463084Labomed Prima DNT Microscope Ceiling Mount Long Arm61372022022-12-13
08908006463091Labomed Prima DNT Microscope Floor Mount Fixed61380012022-12-13
08908006463107Labomed Prima DNT Microscope Floor Mount Fixed Long Arm61380022022-12-13
08908006463114Labomed Magna Floor stand standard arm Microscope61291002022-12-13
08908006463121Labomed Magna Ceiling mount (Standard Arm)61292002022-12-13
08908006463138Labomed Magna Wall mount (Standard Arm)61293002022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975449020022SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020039SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06975449020046SYLChongQing SS Medical Equipments Co., LtdPUE2026-05-14
06973211070930Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070947Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070954Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070961Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070978Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
06973211070985Ophthalmic Slit Lamp MicroscopeCHONGQING SUNKINGDOM MEDICAL INSTRUMENT CO.,LTDPUE2025-08-18
00860010833209ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833247ILLUMINIXIlluminix Industries LLCPUE2024-01-23
00860010833261ILLUMINIXIlluminix Industries LLCPUE2024-01-23
08908006463497LABOMED SLx 40- 3 Step Slit lamp -HL (Halogen)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463503LABOMED SLx 45- 3 Step Slit lamp -HL(Halogen)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463527LABOMED SLx 45- 3 Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463534LABOMED eVO300 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463541LABOMED eVO400 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463558LABOMED eVO300 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463565LABOMED eVO400 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463572LABOMED eVO350 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463589LABOMED eVO450 5-Step Slit lamp -Halogen (HL)LABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463596LABOMED eVO350 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
08908006463602LABOMED eVO450 5-Step Slit lamp -LEDLABOTECH MICROSCOPES INDIA PRIVATE LIMITEDPUE2023-06-17
06972039971405MOPTIMShenzhen CERTAINN Technology Co., Ltd.PUE2022-12-08
07640132985610Imaging SetHaag-Streit AGPUE2022-11-22
07640132986549HeadrestHaag-Streit AGPUE2022-11-22
07640132986556HeadrestHaag-Streit AGPUE2022-11-22
07640132986563HeadrestHaag-Streit AGPUE2022-11-22
07640132986570HeadrestHaag-Streit AGPUE2022-11-22
07640132986600HeadrestHaag-Streit AGPUE2022-11-22