Product code HMF
- Device name
- Stand, Instrument, Ac-Powered, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1860
- 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 |
|---|---|---|---|
| K935945 | ROTA DATAMATE I | Rota Systems,Inc. | 1994-04-19 |
| K935952 | ROTA SYSTEM 5000 | Rota Systems Medfurniture, Inc. | 1994-04-19 |
| K931839 | ROTA SYSTEM XL | Rota Systems Medfurniture, Inc. | 1993-11-22 |
| K930440 | MARCO INTERNATIONAL STAND | Marco Ophthalmic, Inc. | 1993-07-06 |
| K924771 | BURTON OPHTHALMIC STAND - MODEL XL3200 | R.H. Burton Co. | 1993-04-05 |
| K924780 | BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 | R.H. Burton Co. | 1993-04-05 |
| K913961 | OPHTHALMIC STAND | Luneau Ophtalmologie SA | 1991-12-04 |
| K853358 | RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM | Dentsply Intl. | 1985-10-04 |
| K844362 | OPHTHALMIC CHAIR | Luneau Laboratories | 1984-12-11 |
| K844363 | OPHTHALMIC STAND | Luneau Laboratories | 1984-12-05 |
| K832073 | ELECTRIC INSTRUMENT TABLE | CooperVision, Inc. | 1983-08-12 |
| K812544 | RELIANCE OPHTHALMIC INSTRUMENT CONTROL | F. & F. Koenigkramer | 1981-09-21 |
| K803195 | SYSTEM 1 INSTRUMENT STAND | Surgical Mechanical Research, Inc. | 1981-02-04 |
| K791104 | B & L OPHTHALMIC INSTRUMENT STAND | Bausch & Lomb, Inc. | 1979-07-24 |
| K791105 | B & L OPHTHALMIC CHAIR | Bausch & Lomb, Inc. | 1979-07-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05907642694435 | Refraction Unit | MDT SP Z O O | 2025-08-08 |
| 00850020301607 | Reliance | HAAG-STREIT USA, INC. | 2025-08-04 |
| 00850020301614 | Reliance | HAAG-STREIT USA, INC. | 2025-08-04 |
| 00850020301621 | Reliance | HAAG-STREIT USA, INC. | 2025-08-04 |
| 05907642694596 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694589 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694565 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694541 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694459 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694466 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694473 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694480 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694497 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694510 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 05907642694534 | Refraction Unit | MDT SP Z O O | 2025-07-16 |
| 00850020301584 | Reliance | HAAG-STREIT USA, INC. | 2025-05-21 |
| 00850020301539 | Reliance | HAAG-STREIT USA, INC. | 2025-04-24 |
| 00850020301546 | Reliance | HAAG-STREIT USA, INC. | 2025-04-24 |
| 00850020301553 | Reliance | HAAG-STREIT USA, INC. | 2025-04-24 |
| 00850020301560 | Reliance | HAAG-STREIT USA, INC. | 2025-04-24 |
| 00850020301577 | Reliance | HAAG-STREIT USA, INC. | 2025-04-24 |
| 00628308210015 | Lombart | INNOVA Medical Ophthalmics Inc | 2025-02-20 |
| 00628308210022 | S4 Optik | INNOVA Medical Ophthalmics Inc | 2025-02-20 |
| 00628308210039 | Marco | INNOVA Medical Ophthalmics Inc | 2025-02-20 |
| G699Q90630 | EyeCheq Kiosk | EYECHEQ INC. | 2024-10-17 |
| 05907642694442 | Refraction Unit | MDT SP Z O O | 2024-06-14 |
| 04053755199686 | WALL TRANSFORMER EN 200-1 | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 04053755199679 | WALL TRANSFORMER EN 200 | Heine Optotechnik GmbH & Co. KG | 2022-12-12 |
| 10840143904035 | AtriCure System Cart | ATRICURE, INC. | 2021-01-11 |
| 10840143901522 | AtriCure System Cart | ATRICURE, INC. | 2021-01-11 |