FDA Introduces Draft Guidance on Patient Labeling Information for LASIK Devices

The U.S. Food and Drug Administration (FDA) on July 28 released a draft guidance paper that included recommendations for the content and presentation of patient labeling information for LASIK device labels.

FDA Introduces Draft Guidance on Patient Labeling Information for LASIK Devices
August 02, 2022
Belkin Vision's Eagle Device for Glaucoma Receives CE Mark Under MDR

Israel-based Belkin Vision announced that it has received CE Mark for its Eagle device, making it the first automated, non-contact glaucoma laser treatment available within Europe.

Belkin Vision's Eagle Device for Glaucoma Receives CE Mark Under MDR
May 17, 2022
Oertli Instrumente Announces New Features for the OS 4 Surgical Platform

Oertli's OS 4 platform is a powerful, multifaceted system designed for retinal, glaucoma, and cataract surgeries. At its core lies a 3-pump mechanism featuring vacuum and flow regulation, as well as a novel SPEEP pump.

Oertli Instrumente Announces New Features for the OS 4 Surgical Platform
March 10, 2023
Eyenovia Announces FDA Acceptance of NDA for MydCombi for In-Office Pupil Dilation

MydCombi is a drug-device combination solution that uses the investigational Optejet drug delivery technology to deliver the company's unique, first-in-class combination of tropicamide and phenylephrine for in-office pupil dilation (mydriasis).

Eyenovia Announces FDA Acceptance of NDA for MydCombi for In-Office Pupil Dilation
December 14, 2022
Italian Patients Receive Samsara Vision’s SING IMT, a New Technology for AMD

Samsara Vision announced the first three successful clinical cases in Italy using its SING IMT (Smaller-Incision New-Generation Implantable Miniature Telescope) for people living with late-stage, age-related macular degeneration (AMD).

Italian Patients Receive Samsara Vision’s SING IMT, a New Technology for AMD
February 23, 2022
LENSAR Announces FDA Acceptance of 510(k) Submission for ALLY Adaptive Cataract Treatment System

LENSAR announced that the U.S. Food and Drug Administration (FDA) has accepted its 510(k) submission for its next-generation ALLY Adaptive Cataract Treatment System for substantive review.

LENSAR Announces FDA Acceptance of 510(k) Submission for ALLY Adaptive Cataract Treatment System
March 02, 2022
Haag-Streit Launches the Imaging Module 910 Slit Lamp

Haag-Streit announced the launch of the Imaging Module 910 slit lamp. The device is instantly ready by the turn of a knob and does not require using software. Haag-Streit says capturing images is equally easy—pressing the camera trigger button is all that

Haag-Streit Launches the Imaging Module 910 Slit Lamp
March 29, 2022
Icare USA Gets FDA Clearance of iCare HOME2 Self-Tonometer

Icare USA announced 510(k) clearance from the FDA for their next generation self-tonometer, the iCare HOME2.

Icare USA Gets FDA Clearance of iCare HOME2 Self-Tonometer
March 30, 2022
DORC Receives FDA Clearance for Eva Nexus System

DORC International has announced 510(k) market clearance and the launch of the Eva Nexus.

DORC Receives FDA Clearance for Eva Nexus System
July 19, 2022
Nova Eye Medical Launches New Generation Canaloplasty Device for Glaucoma

Nova Eye Medical announced the launch of its next generation canaloplasty device, iTrack Advance, in select markets in Europe and the Asia Pacific.

Nova Eye Medical Launches New Generation Canaloplasty Device for Glaucoma
April 20, 2022
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