optimotionimplants.comVonaFlex Effective Pain Relief Topical Analgesic
LIDOCAINE HYDROCHLORIDE
OPTIMETRICS, INC.
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1038753 | 1038753 | OPTIMETRICS, INC. | 1 | Y | 2026-01-01 | 6095 NW 167TH ST STE D9 Hialeah FL US 33015 |
| 1218141 | 1218141 | OPTIM LLC | 1 | N | 2026-01-01 | 64 TECHNOLOGY PARK RD. Sturbridge MA US 01566 |
| 2085392 | 1000306649 | OPTIMATE, INC. | 1 | Y | 2026-01-01 | 405 LYNROSE ST. ARCADIA CA US 91006 |
| 3003755213 | 3003755213 | OPTIMA PRODUCTS, INC. | 1 | N | 2026-01-01 | 2230 Edgewood Avenue STE 3A Saint Louis Park MN US 55426 |
| 3005675890 | 3005675890 | OptiMedica Corp. | 1 | N | 2026-01-01 | 510 Cottonwood Dr Milpitas CA US 95035 |
| 3006199389 | 3006199389 | OPTIMAL MEDICAL CO., LTD. | 1 | N | 2026-01-01 | No. 11, 1F, 235 Lane, Guo-An 1st Rd. Situn District Taichung City TW 40763 |
| 3012916784 | 3012916784 | OPTIMIZED ORTHO PTY LTD | 1 | N | 2026-01-01 | 17 Bridge Street Sydney New South Wales AU 2073 |
| 3015393207 | 3015393207 | OPTIMAX EYEWEAR INC | 1 | Y | 2026-01-01 | 954 Lexington Ave, Suite 537 New York NY US 10021 |
| 3016470314 | 3016470314 | OPTIMOTION IMPLANTS, LLC | 1 | N | 2026-01-01 | 6052 Turkey Lake Road Suite 170 Orlando FL US 32819 |
| 3039538551 | 3039538551 | OPTIMAL HEALTH SCIENCE, LLC | 1 | Y | 2026-01-01 | 3224 N Maple Grove Rd Boise ID US 83704 |
| 3043532714 | 3043532714 | OPTIMEDI CO., LTD. | 1 | N | 2026-01-01 | 73 Samwon-ro, Deogyang-gu Goyang-si Gyeonggi KR 10550 |
| 3008171035 | 3008171035 | OPTIMUM SOLUTION GROUP, LLC | 1 | Y | 2020-04-25 | 710 W Higgins Rd Ste 102 Park Ridge IL US 60068 |
| 3009550786 | 3009550786 | Optima Health Solutions International Corporation | 1 | N | 2020-04-25 | 303 - 828 W 8th Avenue Vancouver British Columbia CA V5Z 1E2 |
| 3011875106 | 3011875106 | OPTIMUM IMAGING DIAGNOSTICS, LLC | 1 | N | 2020-04-25 | 6 SCIENCE PARK RD STE 1 Scarborough ME US 04074 |
| 3012916784 | 3012916784 | OPTIMIZED ORTHO PTY LTD | 1 | N | 2020-04-25 | 17 Bridge Street Sydney New South Wales AU 2073 |
GUDID Contact Samples
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B6961014F32000 | Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 2 | 877-678-6686 | support@optimotionimplants.com |
| B6961014F33000 | Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 3 | 877-678-6686 | support@optimotionimplants.com |
| B6961014F34000 | Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 4 | 877-678-6686 | support@optimotionimplants.com |
| B6961014F35000 | Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 5 | 877-678-6686 | support@optimotionimplants.com |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 76348 | 1092675388 | K943426 | ARTHROSCOPE,RIGID ROD-LENS DIAGNOSTIC ENDOSCOPE | HRX | 1995-02-01 |
| 76348 | 1896996416 | K864821 | AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-2 | EOB | 1987-02-10 |
| 350052 | 1695416821 | K240938 | The Optimotion Blue Plus Knee System | MBH | 2024-06-27 |
| 350052 | 1593784526 | K220049 | Optimotion Implants Porous Metal-Backed Patella | MBH | 2022-03-14 |
| 346800 | 1227655313 | K202805 | Optimized Positioning System (OPS) Insight | LLZ | 2020-11-20 |
| 346800 | 1580427083 | K193545 | Corin Optimized Positioning System (OPS) Femoral | LZO | 2020-08-04 |
| 346800 | 1099796795 | K193042 | Optimized Positioning System (OPS) ReView | LLZ | 2020-06-26 |
| 346800 | 1939188667 | K192656 | Optimized Positioning System (OPS) Insight | LLZ | 2020-05-01 |
| 350052 | 1754241838 | K191084 | The Optimotion Blue Total Knee System | MBH | 2020-04-07 |
| 346800 | 1320253938 | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | LZO | 2019-07-22 |
| 196485 | 1727645490 | K190834 | Corin Optimized Position System Functional Hip Analysis (OPS FHA) | LZO | 2019-07-22 |
| 196485 | 1352428132 | K183038 | Corin Optimized Positioning System (OPS) Plan | LLZ | 2018-11-26 |
| 346800 | 1758975999 | K183038 | Corin Optimized Positioning System (OPS) Plan | LLZ | 2018-11-26 |
| 196485 | 1621599010 | K181061 | Corin Optimized Positioning System (OPS) Femoral | LZO | 2018-09-07 |
| 346800 | 1887699286 | K181061 | Corin Optimized Positioning System (OPS) Femoral | LZO | 2018-09-07 |
| 346800 | 1595568229 | K171847 | Corin Optimized Positioning System (OPS) Plan | LLZ | 2018-04-05 |
| 196485 | 1878641924 | K171847 | Corin Optimized Positioning System (OPS) Plan | LLZ | 2018-04-05 |
| 238750 | 1226820598 | K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | LPL | 2016-12-19 |
| 202775 | 1692923189 | K161455 | Catalys Precision Laser System | OOE | 2016-09-20 |
| 238750 | 1687054755 | K160212 | ACUVUE (senofilcon C) Soft Contact Lens | LPL | 2016-03-28 |
| 346800 | 1117972777 | K152893 | Corin Optimized Positioning System (OPS) | LZO | 2016-06-03 |
| 196485 | 1406630074 | K152893 | Corin Optimized Positioning System (OPS) | LZO | 2016-06-03 |
| 76348 | 1417918402 | K143673 | CMOS Video Nasopharyngoscope System | EOB | 2015-03-04 |
| 202775 | 1835231038 | K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | 2014-09-11 |
| 139272 | 2032121371 | K130666 | KHAN KINETIC TREATMENT (KKT-M2) | LXM | 2014-01-23 |
| 202775 | 1126082280 | K121091 | CATALYS PRECISION LASER SYSTEM | OOE | 2012-08-28 |
| 202775 | 1490834348 | K113479 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | OOE | 2011-12-21 |
| 76348 | 1929811806 | K091829 | PLS PORTABLE LIGHT SOURCE | NTN | 2009-07-28 |
| 76348 | 1964143492 | K080622 | ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 | EOB | 2008-04-02 |
| 139272 | 1670156655 | K060043 | KHAN KINETIC TREATMENT DEVICE (KKT-M1) | LXM | 2006-03-23 |
| 238750 | 2058557833 | K042275 | VISTAKON (SENOFILCON A) SOFT CONTACT LENS | LPL | 2004-10-28 |
| 494 | 2069685215 | K033190 | VISION-TECH YZ SLIT LAMP, MODEL 66 | HJO | 2003-12-04 |
| 494 | 2047834952 | K023676 | APPLANATION TONOMETER | HKX | 2003-04-24 |
| 494 | 1046500577 | ||||
| 494 | 1221598276 | ||||
| 222259 | 1223713105 | ||||
| 222259 | 1330793643 | ||||
| 494 | 1407589502 | ||||
| 494 | 1507787785 | ||||
| 494 | 1580179400 | ||||
| 494 | 1654393406 | ||||
| 222259 | 1718915527 | ||||
| 494 | 1972173542 | ||||
| 76348 | 2005426242 | ||||
| 122970 | 1168761798 | ||||
| 122970 | 1195999004 | ||||
| 122970 | 1241423297 | ||||
| 122970 | 1254229714 | ||||
| 122970 | 1498005012 | ||||
| 347365 | 1511983225 | ||||
| 347365 | 1579077175 | ||||
| 130456 | 1593224131 | ||||
| 346800 | 1668979650 |
Product Codes Associated With Registrations
NDC
PMN
The Optimotion? Blue Plus Knee System
Optimotion Implants, LLC
Optimotion Implants Porous Metal-Backed Patella
Optimotion Implants, LLC
ENTity WiFi Video Nasopharyngoscope System
Optim, LLC
The Optimotion Blue Total Knee System
Optimotion Implants, LLC
Spinalytics
Optima Health Solutions International Corp.
Catalys Precision Laser System
Optimedica Corporation
IdentEvent
OPTIMA NEUROSCIENCE, INC.
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
OPTIMEDICA CORPORATION
KHAN KINETIC TREATMENT (KKT-M2)
OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION
ELECTRODE, FLEXIBLE SUCTION COAGULATOR
OPTIM, LLC.
PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2
OPTIM LLC
CATALYS PRECISION LASER SYSTEM
OPTIMEDICA CORPORATION
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
OPTIMEDICA CORPORATION
PASCAL STREAMLINE PHOTOCOAGULATOR
OPTIMEDICA CORPORATION
IDENTEVENT, VERSION 1.0G
OPTIMA NEUROSCIENCE, INC.
PLS PORTABLE LIGHT SOURCE
OPTIM, INC.
PASCAL PHOTOCOAGULATOR, PASCAL-US
OPTIMEDICA CORPORATION
PASCAL SYNTHESIS DELIVERY SYSTEM
OPTIMEDICA CORPORATION
ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105
OPTIM, INC.
OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE
OPTIMEDICA CORPORATION
KHAN KINETIC TREATMENT DEVICE (KKT-M1)
OPTIMA HEALTH SOLUTIONS INTERNATIONAL, INC.
OPTIVU HDVD SYSTEM
OPTIMIZE, INC.
OIS-2500 DIAGNOSTIC ULTRASOUND SYSTEM
OPTIMAL IMAGING SYSTEMS, INC.
OIS-STAND ALONE DIAGNOSTIC ULTRASOUND SYSTEM
OPTIMAL IMAGING SYSTEMS, INC.
OPTIVIEW
OPTIMED TECHNOLOGIES, INC.
NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS
OPTIMAXX INTL.
BOOSTER TROPHY 5 MOTORIZED SCOOTER
OPTIMED TECHNOLOGIES, INC.
BOOSTER LITE 3 MOTORIZED SCOOTER
OPTIMED TECHNOLOGIES, INC.
BOOSTER LITE 4 MOTORIZED SCOOTER
OPTIMED TECHNOLOGIES, INC.
OPTIBOND; OPTIAID, OPTIREP, OPTISHINE, OPTICHROMA, OPTIFARB & OPTIWAK
OPTIMAL DENTAL (USA)
NEUROLOGY ACCESSORIES - MARK-EASY 10-20
OPTIMIT USA, INC.
FLEXIBLE FIBER OPTIC LAPAROSCOPES
OPTIMED TECHNOLOGIES, INC.
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
OPTIMED TECHNOLOGIES, INC.
HYSTEROSCOPE (AND ACCESSORIES)
OPTIMED TECHNOLOGIES, INC.
FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE
OPTIMED TECHNOLOGIES, INC.
OPHTHALMIC TRIAL LENSES
OPTIMARK ACCESSORIES AND INSTRUMENTS
ARTHROSCOPE & ACCESSORIES
OPTIMED TECHNOLOGIES, INC.
FLEXIBLE FIBER OPTIC ENDOSCOPE
OPTIMED TECHNOLOGIES, INC.
ENDOSCOPE
OPTIMED TECHNOLOGIES, INC.
FLEXIBLE FIBER OPTIC ENDOSCOPE
OPTIMED TECHNOLOGIES, INC.
Applications
GUDID
Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 2
2026-01-07
Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 3
2026-01-07
Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 4
2026-01-07
Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 5
2026-01-07
Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 6
2026-01-07
Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 7
2026-01-07
Optimotion Blue CR HCCR Total Knee System - FEMORAL PS, SIZE 8
2026-01-07
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 6, 21 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 8, 21 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 8, 19 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 8, 17 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 8, 15 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 8, 13 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 8, 11 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 8, 9 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 7, 21 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 7, 19 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 7, 17 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 7, 15 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 7, 13 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 7, 11 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 7, 9 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 6, 19 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 6, 17 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 6, 15 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 6, 13 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 6, 11 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 6, 9 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 5, 21 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 5, 19 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 5, 17 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 5, 15 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 5, 13 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 5, 11 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 5, 9 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 4, 21 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 4, 19 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 4, 15 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 4, 13 MM
2024-09-11
Optimotion Blue CR HCCR Total Knee System - TIBIAL INSERT HP PS SZ 4, 11 MM
2024-09-11