Product code HJM
- Device name
- Transilluminator, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1945
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972506 | INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR | Infinitech, Inc. | 1997-10-01 |
| K950529 | PEREGRINE DIFFUSION LIGHT PIPE | Peregrine Surgical , Ltd. | 1995-06-07 |
| K945877 | WECO ENDOSCOPIC SYSTEMS WITH FIBER OPTIC LIGHT | Wells Johnson Co. | 1995-03-02 |
| K931072 | HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBE | Hgm, Inc. | 1994-11-10 |
| K933445 | DPS 100 MULTIPORT ILLUMINATION SYSTEM (MIS) | Storz Instrument Co. | 1994-09-23 |
| K940393 | PEREGRINE WIDE ANGLE LIGHT PIPE | Peregrine Surgical , Ltd. | 1994-09-02 |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | Visitec Co. | 1994-05-17 |
| K913273 | DROLITE(TM) LIGHT SOURCE | Vision Medical, Inc. | 1991-12-04 |
| K894513 | DIATHRON(R) DIATHERMY UNIT | Intl. Ophthalmic Industries Corp. | 1989-10-31 |
| K893170 | VISTA FINOFF TRANSILLUMINATOR (AC-POWERED) | Keeler Instruments, Inc. | 1989-06-05 |
| K812949 | RMI TRANSILLUMINATOR, MODEL 292 | Radiation Measurements, Inc. | 1981-12-02 |
| K811108 | RMI TRANSILLUMINATION LIGHT METER #295 | Radiation Measurements, Inc. | 1981-07-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04053755202973 | FINOFF TRANSILLUMINATOR | Heine Optotechnik GmbH & Co. KG | 2025-07-17 |
| 00810123483150 | Vortex Surgical Inc. | Vortex Surgical, Inc. | 2025-04-18 |
| 00810123483167 | Vortex Surgical Inc. | Vortex Surgical, Inc. | 2025-04-18 |
| 10632307002370 | 23GA Midfield Endoillumination Probe | Peregrine Surgical, Llc | 2024-09-24 |
| 10632307002363 | 27GA Midfield Endoillumination Probe | Peregrine Surgical, Llc | 2024-09-24 |
| 10632307002356 | 25GA Midfield Endoillumination Probe | Peregrine Surgical, Llc | 2024-09-24 |
| 00632307002359 | 25GA Midfield Endoillumination Probe | Peregrine Surgical, Llc | 2024-09-24 |
| 00632307002366 | 27GA Midfield Endoillumination Probe | Peregrine Surgical, Llc | 2024-09-24 |
| 00632307002373 | 23GA Midfield Endoillumination Probe | Peregrine Surgical, Llc | 2024-09-24 |
| 04053755200429 | FINOFF TRANSILLUMINATOR | Heine Optotechnik GmbH & Co. KG | 2022-12-21 |
| 04053755120109 | OPHTHALMIC EXAMINATION LAMP | Heine Optotechnik GmbH & Co. KG | 2022-12-21 |
| 04053755119943 | OPHTHALMIC EXAMINATION LAMP | Heine Optotechnik GmbH & Co. KG | 2022-12-21 |
| 04053755199679 | WALL TRANSFORMER EN 200 | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 04053755199686 | WALL TRANSFORMER EN 200-1 | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 00812594013072 | NeoGlo Disposable | NEOTECH PRODUCTS, INC. | 2021-05-20 |
| 00812594013089 | NeoGlo Disposable | NEOTECH PRODUCTS, INC. | 2021-05-20 |
| 10812594013086 | NeoGlo® Disposable | Neotech Products LLC | 2021-05-20 |
| 10812594013079 | NeoGlo® Disposable | Neotech Products LLC | 2021-05-20 |
| 10841305112138 | Synergetics | SYNERGETICS USA, INC. | 2020-05-31 |
| 20841305112142 | Synergetics | SYNERGETICS USA, INC. | 2020-05-31 |
| 07290109140766 | Acculite™ EndoOcular® | LUMENIS INC. | 2016-09-25 |
| 07290109140759 | Acculite™ EndoOcular® | LUMENIS INC. | 2016-09-12 |
| 20841305110094 | Synergetics | SYNERGETICS USA, INC. | 2016-06-24 |
| 20841305110117 | Synergetics | SYNERGETICS USA, INC. | 2016-06-24 |
| 20841305110131 | Synergetics | SYNERGETICS USA, INC. | 2016-06-24 |
| 00632307001291 | 20GA Wide Angle Light Pipe - DORC | Peregrine Surgical, Llc | 2016-05-06 |
| 00632307001253 | 20GA Wide Angle Light Pipe - Standard | Peregrine Surgical, Llc | 2016-05-06 |
| 00632307001192 | 20GA Wide Angle Light Pipe - 297 Connector | Peregrine Surgical, Llc | 2016-05-06 |
| 00632307001130 | 20GA Wide Angle Light Pipe - 287 Connector | Peregrine Surgical, Llc | 2016-05-06 |
| 00632307001017 | 20GA Wide Angle Light Pipe | Peregrine Surgical, Llc | 2016-05-06 |