Product code HOS
- Device name
- Projector, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1680
- 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 |
|---|---|---|---|
| K936200 | WIRELESS CHART PROJECTOR,HCP-W 721 | Canon USA, Inc. | 1994-09-28 |
| K930443 | MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE | Marco Ophthalmic, Inc. | 1993-07-06 |
| K924784 | BURTON PROJECTOR HEAD - MODEL 6000-H | R.H. Burton Co. | 1993-04-05 |
| K921214 | OPHTHALMIC PROJECTOR | Luneau Ophtalmologie SA | 1992-06-11 |
| K890992 | WOODLYN OPHTHALMIC PROJECTOR | Woodlyn, Inc. | 1989-05-17 |
| K862519 | BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR | Bausch & Lomb, Inc. | 1986-07-23 |
| K812706 | MILLER/NADLER GLARE TESTER | Mosebach Electric & Supply | 1981-11-16 |
| K811180 | ULTRAMATIC PROJECT-O-CHART OPHTH. PROJ | American Optical Corp. | 1981-05-15 |
| K781658 | PROJECTOR, ACCU-CHART ACUITY | Bausch & Lomb, Inc. | 1978-10-17 |
Related GUDID Devices#
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|---|---|---|---|
| 03615020000113 | CP 550 | ESSILOR INTERNATIONAL | 2026-02-23 |
| 00850053428500 | VisiChart | TOPCON HEALTHCARE INC | 2023-06-20 |
| 04560323640902 | TAKAGI | TAKAGI SEIKO CO.,LTD. | 2023-06-09 |
| 04562123289206 | AUTO CHART PROJECTOR ACP-8 | TOPCON CORPORATION | 2022-08-31 |
| 00850040295047 | M&S Technologies Smart System® 20/20 | The Hilsinger Company Parent LLC | 2022-07-06 |
| 00850040295108 | M&S Technologies Smart System® 20/20 Tablet | The Hilsinger Company Parent LLC | 2022-07-06 |
| 00850040295191 | M&S Technologies Smart System® PC-Plus | The Hilsinger Company Parent LLC | 2022-07-06 |
| 00850040295559 | M&S Technologies Smart System® Standard | The Hilsinger Company Parent LLC | 2022-07-06 |
| 00850040295351 | M&S Technologies ACUITYex | The Hilsinger Company Parent LLC | 2022-07-06 |
| 00850040295214 | M&S Technologies Melbourne Rapid Fields Device In-Clinic | The Hilsinger Company Parent LLC | 2022-07-06 |
| 00850040295139 | M&S Technologies Clinical Trial Suite® | The Hilsinger Company Parent LLC | 2022-07-06 |
| 00850040295122 | M&S Technologies Smart System® Virtual Reality Headset System | The Hilsinger Company Parent LLC | 2022-07-06 |
| 00850040295016 | M&S Technologies VisiChart® Acuity Chart | The Hilsinger Company Parent LLC | 2022-07-06 |
| 00813125016838 | Head-Up-Display, HUD-1 | IRIDEX CORPORATION | 2021-12-05 |
| 08809358430314 | Medizs Auto Chart Projector CP-11 | MEDIZS Inc. | 2021-03-23 |
| 06971821404015 | Auto chart projector | Ningbo Ming Sing Optical R & D Co., Ltd. | 2020-08-05 |
| 08800019600220 | Chart Projector CCP-3100 | Huvitz Co., Ltd. | 2019-05-10 |
| 08800019600237 | Chart Projector HCP-7000 | Huvitz Co., Ltd. | 2019-05-10 |
| 06945033902058 | TIANNUO / TNMED | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 2018-09-24 |
| 06945033902065 | TIANNUO / TNMED | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 2018-09-24 |
| 00855005006218 | Head-Up-Display, HUD-1 | TOPCON MEDICAL LASER SYSTEMS, INC. | 2018-02-12 |