Product code FSP
- Device name
- Loupe, Diagnostic/Surgical
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4800
- 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 |
|---|---|---|---|
| K895248 | IMS5000 ILLUMINATED LOUPES | Luxtec Corp. | 1989-09-15 |
| K891895 | SURGICAL LOUPES | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K864386 | LUXTEC LOUPES FOR SURGICAL VISION | Luxtec Corp. | 1986-11-17 |
| K861749 | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE | Keeler Instruments, Inc. | 1986-05-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00634782100551 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2023-12-27 |
| 00615375009970 | Orascoptic - RDH Elite Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00850036373025 | Orascoptic - Dragonfly HDL 2.5 Micro | METREX RESEARCH, LLC | 2022-12-08 |
| 00850036373018 | Orascoptic - Dragonfly HDL 2.5 Macro Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00850036373001 | Orascoptic - Dragonfly HDL 2.5 Macro | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375012093 | Orascoptic - HDL 3.5 Galilean Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375011744 | Orascoptic - HDL 3.5 Galilean | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375010112 | Orascoptic - Safety Frame Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375010099 | Orascoptic - OmniOptic Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375010068 | Orascoptic - EyeZoom Mini Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375010044 | Orascoptic - HDL 5.5 Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375010020 | Orascoptic - HDL 4.5 Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375010006 | Orascoptic - HDL 3.5 Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 10615375009601 | Orascoptic - OmniOptic HDL 3.5 | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009956 | Orascoptic - EyeZoom Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009857 | Orascoptic - HDL 3.0 Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009833 | Orascoptic - HDL 2.5 Micro Rx | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009574 | Orascoptic - OmniOptic | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375009550 | Orascoptic - Safety Frame | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008676 | Orascoptic - EyeZoom Mini | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008652 | Orascoptic - HDL 5.5 | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008638 | Orascoptic - HDL 4.5 | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375008614 | Orascoptic - HDL 3.5 | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375001295 | Orascoptic - RDH Elite | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375001271 | Orascoptic - EyeZoom | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375001172 | Orascoptic - HDL 3.0 | METREX RESEARCH, LLC | 2022-12-08 |
| 00615375001158 | Orascoptic - HDL 2.5 Micro | METREX RESEARCH, LLC | 2022-12-08 |
| 10615375009618 | Orascoptic - OmniOptic HDL 4.5 | METREX RESEARCH, LLC | 2022-12-08 |
| 00634782076719 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-10-28 |
| 00634782076702 | Diagnostix™ | AMERICAN DIAGNOSTIC CORP | 2016-09-21 |