Product code HRJ
- Device name
- Table, Instrument, Powered, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4855
- 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 |
|---|---|---|---|
| K930447 | MARCO H AND TS-1 INSTRUMENT TABLES | Marco Ophthalmic, Inc. | 1993-07-06 |
| K922242 | 910T MONTORIZED INSTRUMENT TABLE | R.H. Burton Co. | 1992-09-30 |
| K912134 | TBD, LENS MEASURING DEVICE | Alcon Laboratories | 1991-07-25 |
| K853744 | TECHNA VISION, INC.ELECTRIC TABLE | Techna Vision | 1985-10-17 |
| K853359 | RELIANCE 1379 | Dentsply Intl. | 1985-09-24 |
| K841760 | WOODLYN CLASSIC INSTRUMENT STAND | Woodlyn, Inc. | 1984-06-19 |
| K833820 | MACHEMER/TANO ROTATING | Optical Micro Systems, Inc. | 1984-01-04 |
Related GUDID Devices#
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|---|---|---|---|
| 05904815700467 | Electric table HE Spectralis BR 110-230V | CX ENGINEERING SP Z O O | 2026-04-01 |
| 00628308210459 | S4Optik | INNOVA Medical Ophthalmics Inc | 2026-03-31 |
| 00628308210435 | S4Optik | INNOVA Medical Ophthalmics Inc | 2026-03-31 |
| 04260647940022 | Sliding keyboard shelf | AKRUS GmbH & Co. KG | 2025-11-28 |
| 04260647940039 | Footrest extension | AKRUS GmbH & Co. KG | 2025-11-28 |
| 00628308210350 | S4 OPTIK | INNOVA Medical Ophthalmics Inc | 2025-08-21 |
| 00628308210367 | S4 OPTIK | INNOVA Medical Ophthalmics Inc | 2025-08-21 |
| 00628308210343 | S4 OPTIK | INNOVA Medical Ophthalmics Inc | 2025-08-21 |
| 00628308210336 | S4 OPTIK | INNOVA Medical Ophthalmics Inc | 2025-08-21 |
| 00850003069616 | AIT-250W | TOPCON HEALTHCARE INC | 2025-07-17 |
| 05907642694329 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694343 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694336 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694312 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694305 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694299 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694282 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694275 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694268 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694237 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694220 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694213 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
| 05907642694206 | Ophthalmic Electric Table | MDT SP Z O O | 2025-07-16 |
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| 04260647946239 | Instrument delivery table ak 106 | AKRUS GmbH & Co. KG | 2023-12-04 |
| 04260647940015 | IT 1060.i | AKRUS GmbH & Co. KG | 2023-12-04 |
| 04260647940008 | IT 760.i | AKRUS GmbH & Co. KG | 2023-11-30 |