FDA.reportPublic FDA data

Luneau

Primary DI
03664188000138
Brand
Luneau
Company
LUNEAU TECHNOLOGY OPERATIONS
Model
Tonometer separation prisms L900 -box of 20
Device description
The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.
Published
2023-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HKYTonometer, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKYTonometer, ManualOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K023838000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K023838000LUNEAU STERILE TONOMETER SEPARATION PRISMSLuneau SA2003-02-20HKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03664188000138PrimaryGS10
03664188000114Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03664188000138036641880001383664188000138
03664188000114036641880001143664188000114

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic tonometer tip coverA device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. It is made of natural rubber latex or synthetic polymer materials. This is a single-use device.

Regulatory Flags#

DUNS number
260432380
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03664188000060VisionixVX1102023-06-08
03664188000145Visionix VX650VX650100058442023-06-08
03664188000602VISIONIXVX40 Pro2025-09-05
03664188000589ZEISSVISUREF 10002025-03-11
03664188000077VISIONIXVX652025-01-02
03664188000169VISIONIXVX902025-01-02
03664188000312LuneauL12 Aesthesiometer2025-01-02
03664188000435ESSILORRetina 800RET1IN2025-01-02
03664188000558ESSILORWAM 700+2025-01-02
03664188000565ESSILORWAM 8002025-01-02
03664188000411VisionixVX6102024-04-30
03664188000084VisionixEyeRefract2023-06-15
03664188000008VisionixVX70 2x2023-06-08
03664188000015VisionixVX70 5x2023-06-08
03664188000091VisionixVX70 3x2023-06-08
03664188000152VisionixVX222023-06-08
03664188000176VisionixVX252023-06-08
03664188000220VisionixL2 Skiascopy racks2023-06-08
03664188000237VisionixVX22-NP2023-06-08
03664188000244VisionixVX22-LP2023-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841668146477KATENAKATENA PRODUCTS, INC.HKY2026-03-02
10841668146474KATENAKATENA PRODUCTS, INC.HKY2026-03-02
06430033851920iCare ST500ICARE FINLAND OYHKY2025-12-05
06430033852415iCare IC100ICARE FINLAND OYHKY2025-12-04
06430033852514iCare IC200ICARE FINLAND OYHKY2025-12-04
00812559012485" Ocu-Film® +"""REICHERT, INC.HKY2025-08-15
00812559012492"Ocu-Film® +"""REICHERT, INC.HKY2025-08-14
00812559012454Ocu-Dot® Tonometer Probes - 100 CountREICHERT, INC.HKY2025-08-12
00812559010900Tono-Vera® Tonometer Starter Kit, RechargeableREICHERT, INC.HKY2025-08-12
00812559011945Tono-Vera® Tonometer Starter Kit, AA BatteryREICHERT, INC.HKY2025-08-12
00812559012324Ocu-Dot® Tonometer Probes - 100 CountREICHERT, INC.HKY2025-08-12
00757770407309Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770408856Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770417629Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770420803Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
00757770426867Bausch + LombBausch & Lomb IncorporatedHKY2024-12-30
06430033851784ST500 SmartCradleICARE FINLAND OYHKY2024-11-07
06430033851791ST500 AdapterICARE FINLAND OYHKY2024-11-07
06430033851807ST500 RemoteICARE FINLAND OYHKY2024-11-07
06430033851883iCare ST500ICARE FINLAND OYHKY2024-11-07
00887482112366Symmetry Allen-SchiotzASPEN SURGICAL PRODUCTS, INC.HKY2024-08-20
06430033851098iCare PATIENT2ICARE FINLAND OYHKY2024-04-23
06430033851104iCare PATIENT2ICARE FINLAND OYHKY2024-04-23
06430033851463iCare IC200ICARE FINLAND OYHKY2023-06-20
08800019600411Applanation Tonometer HT-5000Huvitz Co., Ltd.HKY2023-06-12
04560323648564TAKAGITAKAGI SEIKO CO.,LTD.HKY2023-06-09
03664188000114LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
00860000603805Automated Ophthalmics Softips AUTOMATED OPHTHALMICS, INC.HKY2022-11-17
00860412001541CATSZIEN MEDICAL TECHNOLOGIES, INC.HKY2022-10-12
00860412001558CATSZIEN MEDICAL TECHNOLOGIES, INC.HKY2022-10-12