Labtician Ophthalmics Inc

FDA Filings

This page includes the latest FDA filings for Labtician Ophthalmics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9612327
• FEI Number: 3002807445
• Name: Emily M. Digenis
• Owner & Operator: LABTICIAN OPHTHALMICS, INC.
• Contact Address: 2140 WINSTON PARK DR., UNIT 6 --; OAKVILLE CA-ON Ontario L6H 5V5 CA
• Official Correspondent:
  • Phil Cuscuna
  • 1-905-8290055-x
• US Agent:
  • Emily M. Digenis
  • Attorney at Law
  • 502 5895544
  • emilydigenis@gmail.com
• Importing Logistics Registration:
  • Importer: Kelly Comfort Solutions
  • Address: 2601 Hunters Point Court S. ; Wexford, PA 15090 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3909 Zaring Mill Ct ; Barbourmeade, KY 40241 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00871321000297 Labtician Ophthalmics, Inc	Labtician Lid Load Adhesive Strips NST 400	2021-08-11
GUDID 00871321002956 Labtician Ophthalmics, Inc	LLL Proportional 2.0 grams	2021-04-30
GUDID 10871321002595 Labtician Ophthalmics, Inc	Combo Pack	2021-01-28
GUDID 10871321002571 Labtician Ophthalmics, Inc	Combo Pack	2021-01-28
GUDID 10871321002526 Labtician Ophthalmics, Inc	LabVit Kit N/A	2021-01-28
GUDID 10871321002380 Labtician Ophthalmics, Inc	Labtician Buckling Sleeve™	2021-01-28
GUDID 10871321002342 Labtician Ophthalmics, Inc	Labtician Buckling Sleeve™	2021-01-28
GUDID 10871321002304 Labtician Ophthalmics, Inc	Combo Pack	2021-01-28
GUDID 10871321002281 Labtician Ophthalmics, Inc	Silicone Tire Wide Groove	2021-01-28
GUDID 10871321002267 Labtician Ophthalmics, Inc	Silicone Strip	2021-01-28
GUDID 10871321002236 Labtician Ophthalmics, Inc	Wong Meridional Implant	2021-01-28
GUDID 10871321002106 Labtician Ophthalmics, Inc	Combo Pack	2021-01-28
GUDID 10871321002090 Labtician Ophthalmics, Inc	Combo Pack	2021-01-28
GUDID 10871321002069 Labtician Ophthalmics, Inc	Combo Pack	2021-01-28
GUDID 10871321002052 Labtician Ophthalmics, Inc	Double Tantalum Clip 2.5mm	2021-01-28
GUDID 10871321002045 Labtician Ophthalmics, Inc	Double Tantalum Clip 2.0mm	2021-01-28
GUDID 10871321002021 Labtician Ophthalmics, Inc	Silicone Lace™ 2.5mm	2021-01-28
GUDID 10871321002014 Labtician Ophthalmics, Inc	Silicone Lace™ 2mm	2021-01-28
GUDID 10871321001987 Labtician Ophthalmics, Inc	Silicone Strip	2021-01-28
GUDID 10871321001970 Labtician Ophthalmics, Inc	Silicone Strip	2021-01-28
GUDID 10871321001963 Labtician Ophthalmics, Inc	Silicone Strip	2021-01-28
GUDID 10871321001956 Labtician Ophthalmics, Inc	Labtician Oval Sleeve™	2021-01-28
GUDID 10871321001949 Labtician Ophthalmics, Inc	Labtician Oval Sleeve™	2021-01-28
GUDID 10871321001932 Labtician Ophthalmics, Inc	Silicone Sleeve	2021-01-28
GUDID 10871321001925 Labtician Ophthalmics, Inc	Wedge	2021-01-28
GUDID 10871321001918 Labtician Ophthalmics, Inc	Wedge	2021-01-28
GUDID 10871321001901 Labtician Ophthalmics, Inc	Meridional Implant	2021-01-28
GUDID 10871321001895 Labtician Ophthalmics, Inc	Silicone Sleeve	2021-01-28
GUDID 10871321001888 Labtician Ophthalmics, Inc	Silicone Sleeve	2021-01-28
GUDID 10871321001871 Labtician Ophthalmics, Inc	Silicone Tire	2021-01-28
GUDID 10871321001864 Labtician Ophthalmics, Inc	Silicone Tire 10mm	2021-01-28
GUDID 10871321001857 Labtician Ophthalmics, Inc	Silicone Tire 7mm WG	2021-01-28
GUDID 10871321001840 Labtician Ophthalmics, Inc	Silicone Tire 7mm	2021-01-28
GUDID 10871321001833 Labtician Ophthalmics, Inc	Boat	2021-01-28
GUDID 10871321001826 Labtician Ophthalmics, Inc	Boat	2021-01-28
GUDID 10871321001819 Labtician Ophthalmics, Inc	Silicone Tire 6mm	2021-01-28
GUDID 10871321001802 Labtician Ophthalmics, Inc	Silicone Tire 9mm	2021-01-28
GUDID 10871321001796 Labtician Ophthalmics, Inc	Silicone Tire 7.0mm	2021-01-28
GUDID 10871321001789 Labtician Ophthalmics, Inc	Silicone Strip	2021-01-28
GUDID 10871321001772 Labtician Ophthalmics, Inc	Silicone Tire 12.5mm	2021-01-28
GUDID 10871321001765 Labtician Ophthalmics, Inc	Silicone Tire 10mm LG	2021-01-28
GUDID 10871321001758 Labtician Ophthalmics, Inc	Silicone Tire 10mm	2021-01-28
GUDID 10871321001741 Labtician Ophthalmics, Inc	Silicone Tire 8.5mm	2021-01-28
GUDID 10871321001734 Labtician Ophthalmics, Inc	Silicone Tire 6.0mm	2021-01-28
GUDID 10871321001727 Labtician Ophthalmics, Inc	Pad	2021-01-28
GUDID 10871321001710 Labtician Ophthalmics, Inc	2.5mm Grooved Strip	2021-01-28
GUDID 10871321001703 Labtician Ophthalmics, Inc	Silicone Strip	2021-01-28
GUDID 10871321001697 Labtician Ophthalmics, Inc	Silicone Tire 9mm	2021-01-28
GUDID 10871321001680 Labtician Ophthalmics, Inc	Boat	2021-01-28
GUDID 10871321001673 Labtician Ophthalmics, Inc	Meridional Implant	2021-01-28
GUDID 10871321001666 Labtician Ophthalmics, Inc	2.5mm Circling Band	2021-01-28
GUDID 10871321001659 Labtician Ophthalmics, Inc	Circling Band	2021-01-28
GUDID 10871321001642 Labtician Ophthalmics, Inc	Silicone Tire 7mm	2021-01-28
GUDID 10871321001635 Labtician Ophthalmics, Inc	Meridional Implant - Flat	2021-01-28
GUDID 10871321001628 Labtician Ophthalmics, Inc	Silicone Tire 10mm	2021-01-28
GUDID 10871321001369 Labtician Ophthalmics, Inc	Grooved Sponge	2021-01-28
GUDID 00871321002840 Labtician Ophthalmics, Inc	Tantalum Weight 2.4 gram Pink	2021-01-27
GUDID 00871321002833 Labtician Ophthalmics, Inc	Tantalum Weight 2.2 gram Pink	2021-01-27
GUDID 00871321002826 Labtician Ophthalmics, Inc	Tantalum Weight 2.0 gram Pink	2021-01-27
GUDID 00871321002819 Labtician Ophthalmics, Inc	Tantalum Weight 1.8 gram Pink	2021-01-27
GUDID 00871321002802 Labtician Ophthalmics, Inc	Tantalum Weight 1.6 gram Pink	2021-01-27
GUDID 00871321002796 Labtician Ophthalmics, Inc	Tantalum Weight 1.4 gram Pink	2021-01-27
GUDID 00871321002789 Labtician Ophthalmics, Inc	Tantalum Weight 1.2 gram Pink	2021-01-27
GUDID 00871321002772 Labtician Ophthalmics, Inc	Tantalum Weight 1.0 gram Pink	2021-01-27
GUDID 00871321002765 Labtician Ophthalmics, Inc	Tantalum Weight 0.8 gram Pink	2021-01-27
GUDID 00871321002758 Labtician Ophthalmics, Inc	Tantalum Weight 0.6 gram Pink	2021-01-27
GUDID 00871321002741 Labtician Ophthalmics, Inc	Tantalum Weight 2.8 gram	2021-01-27
GUDID 00871321002734 Labtician Ophthalmics, Inc	Tantalum Weight 2.6 gram	2021-01-27
GUDID 00871321002727 Labtician Ophthalmics, Inc	Tantalum Weight 2.4 gram	2021-01-27
GUDID 00871321002710 Labtician Ophthalmics, Inc	Tantalum Weight 2.2 gram	2021-01-27
GUDID 00871321002703 Labtician Ophthalmics, Inc	Tantalum Weight 2.0 gram	2021-01-27
GUDID 00871321002697 Labtician Ophthalmics, Inc	Tantalum Weight 1.8 gram	2021-01-27
GUDID 00871321002680 Labtician Ophthalmics, Inc	Tantalum Weight 1.6 gram	2021-01-27
GUDID 00871321002673 Labtician Ophthalmics, Inc	Tantalum Weight 1.4 gram	2021-01-27
GUDID 00871321002666 Labtician Ophthalmics, Inc	Tantalum Weight 1.2 gram	2021-01-27
GUDID 00871321002659 Labtician Ophthalmics, Inc	Tantalum Weight 1.0 gram	2021-01-27
GUDID 00871321002642 Labtician Ophthalmics, Inc	Tantalum Weight 0.8 gram	2021-01-27
GUDID 00871321002635 Labtician Ophthalmics, Inc	Tantalum Weight 0.6 gram	2021-01-27
GUDID 00871321002611 Labtician Ophthalmics, Inc	Gonio Left	2021-01-27
GUDID 00871321002451 Labtician Ophthalmics, Inc	LLL Proportional 1.8 grams	2021-01-27
GUDID 00871321002444 Labtician Ophthalmics, Inc	LLL Proportional 1.6 grams	2021-01-27
GUDID 00871321002437 Labtician Ophthalmics, Inc	LLL Proportional 1.4 grams	2021-01-27
GUDID 00871321002420 Labtician Ophthalmics, Inc	LLL Proportional 1.2 grams	2021-01-27
GUDID 00871321002413 Labtician Ophthalmics, Inc	LLL Proportional 1.0 grams	2021-01-27
GUDID 00871321002406 Labtician Ophthalmics, Inc	LLL Proportional 0.8 grams	2021-01-27
GUDID 00871321002390 Labtician Ophthalmics, Inc	LLL Proportional 0.6 grams	2021-01-27
GUDID 00871321002215 Labtician Ophthalmics, Inc	LSO QuickSet N/A	2021-01-27
GUDID 00871321001164 Labtician Ophthalmics, Inc	Labtician Lid Load™ 2.8 grams	2021-01-27
GUDID 00871321001157 Labtician Ophthalmics, Inc	Labtician Lid Load™ 2.6 grams	2021-01-27
GUDID 00871321001140 Labtician Ophthalmics, Inc	Labtician Lid Load™ 2.4 grams	2021-01-27
GUDID 00871321001133 Labtician Ophthalmics, Inc	Labtician Lid Load™ 2.2 grams	2021-01-27
GUDID 00871321001126 Labtician Ophthalmics, Inc	Labtician Lid Load™ 2.0 grams	2021-01-27
GUDID 00871321001119 Labtician Ophthalmics, Inc	Labtician Lid Load™ 1.8 grams	2021-01-27
GUDID 00871321001102 Labtician Ophthalmics, Inc	Labtician Lid Load™ 1.6 grams	2021-01-27
GUDID 00871321001096 Labtician Ophthalmics, Inc	Labtician Lid Load™ 1.4 grams	2021-01-27
GUDID 00871321001089 Labtician Ophthalmics, Inc	Labtician Lid Load™ 1.2 grams	2021-01-27
GUDID 00871321001072 Labtician Ophthalmics, Inc	Labtician Lid Load™ 1.0 grams.	2021-01-27
GUDID 00871321001065 Labtician Ophthalmics, Inc	Labtician Lid Load™ 0.8 grams	2021-01-27
GUDID 00871321001058 Labtician Ophthalmics, Inc	Labtician Lid Load™ 0.6 grams	2021-01-27
GUDID 00187132100294 Labtician Ophthalmics, Inc	Labtician Lid Load Adhesive Strips NST 400	2021-01-27
KDD Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	LabVit Kit	2009-08-20
PMN K990224 | MML Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	Labtician Tantalum External Weight	2007-11-20
PMN K990224 | MML Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	Labtician Lid Load External Eyelid Sizing Weight Set	2007-11-20
PMN K983607 | MML Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	Labtician Lid Load Gold Eyelid Weight Implant	2007-11-20
PMN K875014 | HQJ Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	Labtician Retinal Implant	2007-11-20
PMN K000544 | HJX Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	Boucher DeGroot Head Positioning Glasses	2007-11-20
IQG Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	LSO QUICKSET	2004-10-14
HJX Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080	2000-12-11
PMN K000544 LABTICIAN OPHTHALMICS, INC.	BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080	2000-03-09
KGX Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	LABTICIAN LID LOAD ADHESIVE STRIPS	1999-04-20
HNR Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	Wong Forceps	1999-04-20
HNR Emily M. Digenis [LABTICIAN OPHTHALMICS, INC.]	Frederick Sleeve Spreader	1999-04-20
PMN K990224 LABTICIAN OPHTHALMICS, INC.	LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET	1999-04-12
PMN K983607 LABTICIAN OPHTHALMICS, INC.	LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS	1999-01-08
PMA P930024 LABTICIAN OPHTHALMICS, INC.	GRIESHABER SCLERAL BUCKLING BALLOON CATHETER	1994-06-02