FDA.reportPublic FDA data

Automated Ophthalmics Softips

Primary DI
00860000603805
Brand
Automated Ophthalmics Softips
Company
AUTOMATED OPHTHALMICS, INC.
Model
AO316
Device description
A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.
Published
2022-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K992998000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992998000AUTOMATED OPHTHALMICS SOFTIPSAutomated Ophthalmics, Inc.2000-01-10HKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000603805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000603805008600006038058600006038050860000603805

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. The device is made of plastic. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature35 Degrees Fahrenheit80 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
929977858
Device count
1
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

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
03664188000138LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
03664188000114LuneauLUNEAU TECHNOLOGY OPERATIONSHKY2023-06-08
00860412001541CATSZIEN MEDICAL TECHNOLOGIES, INC.HKY2022-10-12
00860412001558CATSZIEN MEDICAL TECHNOLOGIES, INC.HKY2022-10-12