Accomplishments
Our accomplishments are the product of collaborations with clients as we identify an optimal and individualized pathway
ACCOMPLISHMENTS
Below are some of the many regulatory filings our consultants have partnered with clients to accomplish.
IDE Applications
Approved IDE study applications for Class II and III devices, some of which are first-of-a-kind, including:
- Non-refractory and refractory glaucoma implants
- Femtosecond lasers and excimer lasers for various indications
- Manual instruments to lower IOP in the treatment of glaucoma
- Implants to address corneal and retinal blindness
- Novel plug designs for dry eye disease
- Intraocular refractive and therapeutic ocular implants [phakic and aphakic intraocular lenses (premium and conventional), adjustable IOLs, implantable telescope, capsular tension ring, endotamponades, viscoelastic devices, etc.]
- Radiation therapy for age-related macular degeneration
- Corneal refractive procedures (lasers, inlays, and implants for ametropia, presbyopia, etc.)
510(k) Premarket Notifications (selected, novel technology)
Successful 510(k) clearances, including:
- Amblyopia digital therapeutic device
- Vitrectomy instruments
- Synthetic patch graft for scleral reinforcement/glaucoma implants
- Collagen shields
- Diagnostic imaging and measurement tools including tonometers, biometers, cameras, and OCT
- Diagnostic/monitoring software (home use and clinical use)
- Dry eye therapeutics including novel plug designs for dry eye disease
- Femtosecond lasers in cataract and refractive surgery
- Ophthalmic lasers for other applications (glaucoma, retina, etc.)
- Photocoagulation lasers
- Refractory glaucoma implants
- Subretinal and suprachoroidal therapeutic delivery
- Neurostimulators
- Home vision testing
- Manual instruments to lower intraocular pressure (IOP) in glaucoma and for other indications
De Novo Petitions
Successful Class II De novo petitions, including:
- Smart contact lens
- Tear neurostimulator
- Neurostimulation and light-based therapy for dry eye disease
- Amblyopia digital therapeutic device
- Home-based Optical Coherence Tomograph (OCT)
- Home-use goggles to modulate intraocular pressure
HUD/HDE and Breakthrough Designations
Orphan device designations and approvals, including:
- Retinal prosthesis
- Artificial lens capsule
- Corneal therapeutic devices
- Intraocular lenses
Premarket Approval Applications
Successful PMA approvals, many of which are first-of-a-kind, including:
- Corneal refractive procedures (lasers and implants for ametropia, presbyopia, etc.)
- Glaucoma implants including MIGS devices
- Intraocular refractive and therapeutic ocular implants [phakic and aphakic intraocular lenses (premium and conventional), adjustable IOL’s, implantable telescope, capsular tension ring, endotamponade, viscoelastic devices, etc.]
