Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz)

Basic Information

• Brand Name: Implantable Miniature Telescope (IMT™ by Dr. Isaac Lipshitz)
• Primary DI: M687PR00020000
• Version / Model: WA 2.7X
• Catalog Number: PR00020-00
• Company Name: VISIONCARE OPHTHALMIC TECHNOLOGIES LTD.
• Labeler DUNS: 532007614
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-18
• Public Version: 4
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: 63921f90-5385-4f0a-89f3-001a076d6159

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NCJ	Telescope, Implantable, Miniature	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58434	Intraocular telescope	An implantable optical device designed to improve visual acuity in patients with bilateral moderate to profound central vision impairment due to age related macular degeneration. It is a non-active micro-Galilean telescope consisting of a doublet lens confined in a glass cylinder intended to replace the natural lens of the eye. The device functions together with the cornea as a telephoto system to render an enlarged image on the retina to improve vision. Disposable devices associated with implantation may be included with the lens.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M687PR00020000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P050034	012

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 43 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50.662 – 121.59 KiloPascal