Product code FQP
- Device name
- Lamp, Operating-Room
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4580
- Review panel
- SU
- 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 |
|---|---|---|---|
| K001223 | ACULUX, MODEL AX3001, AX3002 | Aculux | 2000-06-23 |
| K993314 | SYNTHES LIGHT GUIDE | Synthes (Usa) | 1999-12-06 |
| K781581 | SURGICAL LIGHT 22 SERIES | American Sterilizer Co. | 1978-10-17 |
| K770812 | HANDLES, LIGHT, SURGICAL, STEOILE | Sybron Corp. | 1977-05-23 |
| K761018 | SURGICAL LIGHT - CHALLENGE 22 SERIES | Amsco Co. | 1977-01-26 |
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|---|---|---|---|
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| 14589864500282 | OPELAIII Protected Special Package | TAIYO CORPORATION | 2022-07-07 |
| 14589864500312 | OPELAIII calibration kit | TAIYO CORPORATION | 2021-04-07 |
| 14589864500275 | OPELAIII Protected Special Package | TAIYO CORPORATION | 2021-04-07 |
| 14589864500237 | OPELAIII Hard Case | TAIYO CORPORATION | 2021-04-07 |
| 14589864500213 | OPELAIII Cord Clip (Large) | TAIYO CORPORATION | 2020-12-08 |
| 14589864500206 | OPELAIII Cord Clip (Small) | TAIYO CORPORATION | 2020-12-08 |
| 14589864500176 | OPELAIII Antibacterial Urethane Pad | TAIYO CORPORATION | 2020-12-08 |
| 14589864500169 | OPELAIII Storage Bag (with calibration kit) | TAIYO CORPORATION | 2020-12-08 |
| 14589864500152 | OPELAIII Attached Belt (LL) | TAIYO CORPORATION | 2020-12-08 |
| 14589864500145 | OPELAIII Attached Belt (M-L) | TAIYO CORPORATION | 2020-12-08 |
| 14589864500138 | OPELAIII Dedicated AC Adapter | TAIYO CORPORATION | 2020-12-08 |
| 14589864500107 | OPELAIII Standard Package | TAIYO CORPORATION | 2020-12-07 |
| 14589864500121 | OPELAIII Battery Unit | TAIYO CORPORATION | 2020-12-07 |
| 14589864500114 | OPELAIII Main Unit | TAIYO CORPORATION | 2020-12-07 |
| 10705034731094 | NA | Synthes GmbH | 2016-06-30 |
| 10705034771267 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771250 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771243 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771236 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771229 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771212 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771205 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771182 | NA | Synthes GmbH | 2016-06-30 |
| 10705034771144 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771113 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771106 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771090 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771076 | SynFrame | Synthes GmbH | 2016-06-30 |
| 10705034771052 | SynFrame | Synthes GmbH | 2016-06-30 |