Medical device registration holder
Optisurg
82 DRAP registrations and enlistments (7 Class A, 33 Class B, 42 Class C) · Screen a DRAP number · Device types · Companies
DRAP lists
All devices of Optisurg
| DRAP no. | Device | Class | Status |
|---|---|---|---|
| MDIR-0005081 | Bi-Flex (Aspheric hydrophilic acrylic IOL for Implantation into the capsular bag) [677AD] | C | Valid to Apr 2028 |
| MDIR-0005082 | Bi-Flex (Aspheric hydrophilic acrylic IOL for Implantation into the capsular bag) [677ADY] | C | Valid to Apr 2028 |
| MDIR-0005633 | BI-FLEX POB-MA (Hydrophobic Preloaded Intraocular Lens) [877PA, 877PAY] | C | Valid to Oct 2028 |
| MDIR-0006748 | BI-Flex Preloaded Hydrophilic IOL (Intraocular lens) [677P, 677PY] | C | Valid to Apr 2029 |
| MDIR-0005630 | BI-Flex Toric Hydrophilic Aspheric Intraocular Lens (Intraocular Lens) [677AT, 677TAY] | C | Valid to Oct 2028 |
| MDIR-0006576 | Capsulotomy Tip, Standard, Reusable (Capsulotomy Tip) | C | Valid to Apr 2029 |
| MDIR-0006561 | CATARHEX 3 Easy Surgical Platform, Anterior (Ophthalmic surgery system) | C | Valid to Apr 2029 |
| MDIR-0006564 | CATARHEX 3 Surgical Platform, Anterior (Ophthalmic Surgery System) | C | Valid to Apr 2029 |
| MDIR-0001173 | CataRhex3 Phacoemulsification System [without pedal] [VC821100] | C | Renewal passed |
| MDIR-0006575 | Diathermy Handpiece, Short, Reusable (Diathermy Handpiece) | C | Valid to Apr 2029 |
| MDIR-0006573 | Diathermy Tip Eraser, 50 Beveled, Reusable (Diathermy Tips Reusable) | C | Valid to Apr 2029 |
| MDIR-0001718 | Ellex Integre Pro Scan LP6RG Integre Pro Scan LP6RG | C | Renewal passed |
| MDIR-0001717 | Ellex Ultra Q LQP3106-U (Lasers, Ophthalmic, Nd: YAG) | C | Renewal passed |
| MDIR-0005632 | ELON POB-MA (Hydrophobic Preloaded Elongated Depth of Focus Intraocular Lens) [877PEY] | C | Valid to Oct 2028 |
| MDIR-0006574 | Endo Diathermy Tips Reusable (Endo Diathermy Tips Reusable) | C | Valid to Apr 2029 |
| MDIR-0001171 | Faros SurgerySystem Anterior (without dual linear pedal and without remote control) (VC840100) | C | Renewal passed |
| MDIR-0006562 | FAROS Surgical Platform, Anterior/Posterior (Ophthalmic Surgery System) | C | Valid to Apr 2029 |
| MDIR-0001715 | Hoya iSert Preloaded Intraocular Lens [150, 151, 250, 251] | C | Renewal passed |
| MDIR-0005764 | HOYA NanexTM Multisert+TM (Preloaded Intraocular Lens) [NY1-SP (+6D to +30D with an increment of… | C | Valid to Oct 2028 |
| MDIR-0001714 | Hoya Vivinex iSert Preloaded Intraocular Lens [XY1 XC1] | C | Renewal passed |
| MDIR-0005763 | HOYA Vivinex Multisert (Intra-ocular lens (IOL) [XYI-SP] | C | Valid to Oct 2028 |
| MDIR-0001716 | Hoya Vivinex Toric Preloaded Intraocular Lens [XY1AT2, XY1AT3, XY1AT4, XY1AT5, XY1AT6, XY1AT7, XY1AT8, XY1AT9] | C | Renewal passed |
| MDIR-0006864 | HOYA-PS AF-1 (Intraocular Lens) [PC-60AD, PY-60AD] | C | Valid to Apr 2029 |
| MDIR-0001713 | Hoya-PS AF-1 Hoya Preloaded System Intraocular Lens [PC-60R, PY-60R] | C | Renewal passed |
| MDIR-0001168 | Integre Pro LP5532 (Ophthalmic Solid-state laser system, photocoagulation) | C | Renewal passed |
| MDIR-0005628 | Liberty Trifocal Toric Hydrophilic Acrylic Intraocular Lens (Intraocular Lens) [677MTY] | C | Valid to Oct 2028 |
| MDIR-0003716 | Medicontur 677PMY Tri-Focal Bi-Flex Liberty Preloaded (Aspheric hydrophilic acrylic IOL with blue light filter… | C | Valid to Aug 2027 |
| MDIR-0002757 | Medicontur Bi Flex Pre loaded: 677P | C | Renewal passed |
| MDIR-0002758 | Medicontur Bi Flex: 677AB | C | Renewal passed |
| MDIR-0002756 | Medicontur Bi-Flex M: 677MY | C | Renewal passed |
| MDIR-0005631 | Medicontur Medjet PIL-MA (Single Use Injection System) [Medjet PIL-MA] | C | Valid to Oct 2028 |
| MDIR-0001174 | Micron M7 (Excimer Refractive Laser System) | C | Renewal passed |
| MDIR-0006387 | Oertli (Diathermy Tips Reusable) | C | Valid to Feb 2029 |
| MDIR-0006388 | Oertli Cutting Instrument Reusable | C | Valid to Feb 2029 |
| MDIR-0001172 | Oertli Faros Surgery System Anterior Posterior (VC840101) | C | Renewal passed |
| MDIR-0001169 | OS4 Surgery System Anterior/Posterior [with Endolaser, LED and LED Plus light source without Pedal]… | C | Renewal passed |
| MDIR-0001170 | OS4 Surgery System Anterior/Posterior [with LED and LED Plus light source without Pedal] [VC860200] | C | Renewal passed |
| MDIR-0006563 | OS4 Surgical Platform Anterior/Posterior with Endo Laser (Ophthalmic Surgery System) | C | Valid to Apr 2029 |
| MDIR-0005634 | Q-FLEX (Hydrophilic Intraocular Lens) [640AD, 640ADY] | C | Valid to Oct 2028 |
| MDIR-0005629 | Q-Flex PIL-MA Hydrophilic Preloaded Intraocular Lens (Intraocular Lens) [640P, 640PY] | C | Valid to Oct 2028 |
| MDIR-0006386 | U/S Phaco handpiece Hexadisq (reusable) [VG800011] | C | Valid to Feb 2029 |
| MDIR-0001167 | Ultra Q Reflex (LQP3106-U) | C | Renewal passed |
| MDIR-0007481 | Air delivery lines single use | B | Valid to Nov 2029 |
| MDIR-0009848 | Applanation Tonometer [Model: T170] | B | Valid to Jul 2030 |
| MDIR-0007482 | Caliburn trocar systems single use | B | Valid to Nov 2029 |
| MDIR-0007483 | Chandelier illuminator bendable single use | B | Valid to Nov 2029 |
| MDIR-0007484 | Continuous flow cutter single use | B | Valid to Nov 2029 |
| MDIR-0007486 | Endo illuminator panorama single use | B | Valid to Nov 2029 |
| MDIR-0007485 | Endo illuminator single use | B | Valid to Nov 2029 |
| MDIR-0007487 | Endo phaco tips reusable | B | Valid to Nov 2029 |
| MDIR-0002753 | Evolution 3e Control Unit | B | Renewal passed |
| MDIR-0007488 | I/a quick tip, reusable | B | Valid to Nov 2029 |
| MDIR-0007489 | Irrigation sleeve single use | B | Valid to Nov 2029 |
| MDIR-0002750 | M2SU HEAD (M2SU Head of Microkeratome System) [19334/90, 19334/130] | B | Renewal passed |
| MDIR-0002759 | Medjet B1B 2.2 (Single use injector) | B | Renewal passed |
| MDIR-0002748 | ONE USE PLUS SBK HEAD (One Use plus SBK Head Microkeratome) [19393/90, 19393/130] | B | Renewal passed |
| MDIR-0002755 | ONE Vacuum Trephine | B | Renewal passed |
| MDIR-0002754 | ONE Vacuum Trephine Adjustable | B | Renewal passed |
| MDIR-0002752 | ONE-BUSIN GLIDES [ONE-BUSIN GLIDES 17300x5] | B | Renewal passed |
| MDIR-0007996 | OPTOPOL Spectral Optical Coherence Tomographer [REVO 60] | B | Valid to Mar 2030 |
| MDIR-0007997 | OPTOPOL Spectral Optical Coherence Tomographer [REVO 80] | B | Valid to Mar 2030 |
| MDIR-0007998 | OPTOPOL Spectral Optical Coherence Tomographer [REVO FC] | B | Valid to Mar 2030 |
| MDIR-0007999 | OPTOPOL Spectral Optical Coherence Tomographer [REVO NX 130] | B | Valid to Mar 2030 |
| MDIR-0004996 | ORYUM Slit Knife, Angled (Sterile, ophthalmic knife) | B | Valid to Apr 2028 |
| MDIR-0004995 | ORYUM Stab Knife, Straight (Sterile, ophthalmic knife) [YM-15A, YM-30A YM-45A] | B | Valid to Apr 2028 |
| MDIR-0002751 | OUP REUSABLE SUCTION RING (Oup reusable Suction ring of microkeratome system) [19391/-1, 19391/0 19391/1,… | B | Renewal passed |
| MDIR-0002749 | OUP USE PLUS MOTOR [19345] | B | Renewal passed |
| MDIR-0007490 | Phaco set, single use | B | Valid to Nov 2029 |
| MDIR-0007491 | Phaco tips easytip, reusable | B | Valid to Nov 2029 |
| MDIR-0007492 | Phaco tips easytip, single use | B | Valid to Nov 2029 |
| MDIR-0007493 | Silicone injection/extraction set | B | Valid to Nov 2029 |
| MDIR-0007494 | Snap lock visco cannula | B | Valid to Nov 2029 |
| MDIR-0007495 | Universal visco cannula | B | Valid to Nov 2029 |
| MDIR-0007496 | Vitrectomy packs faros single use | B | Valid to Nov 2029 |
| MDIR-0007497 | Vitrectomy packs os4, single use | B | Valid to Nov 2029 |
| MDIE-0002079 | Automatic Fundus Camera [FC162] | A | Valid to Jul 2030 |
| MDIE-0000304 | ONE Punch [17200D700, 17200D725, 17200D750, 17200D775, 17200D800, 17200D825, 17200D850, 17200D875, 17200D900, 17200D950] | A | Renewal passed |
| MDIE-0001113 | OPTOPOL Automated Perimeter [PTS 925W] | A | Valid to Mar 2030 |
| MDIE-0001114 | OPTOPOL Automated Projection Perimeter [PTS 2000] | A | Valid to Mar 2030 |
| MDIE-0001112 | OPTOPOL Automated Projection Perimeter [PTS 920] | A | Valid to Mar 2030 |
| MDIE-0002077 | Portable Slit Lamp Microscope [S150] | A | Valid to Jul 2030 |
| MDIE-0002078 | Slit Lamp Microscope [S290] | A | Valid to Jul 2030 |
Source: DRAP's published provisional lists of registered and enlisted medical devices. A screening aid, not an official DRAP verification.