Product code HJN
- Device name
- Transilluminator, Battery-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1945
- 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#
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06945095544692 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095543787 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544050 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| 06945095544678 | zumax | Zumax Medical Co., LTD | 2026-05-21 |
| B945BERAI0 | Bernell | Bernell | 2026-05-02 |
| B945MTBIFL0 | Bernell | Bernell | 2026-05-02 |
| B945MTBIH20 | Bernell | Bernell | 2026-05-02 |
| 00697077003166 | Amico Diagnostic Illuminator | Amico Diagnostic Incorporated | 2026-02-24 |
| 00697077003173 | Amico Diagnostic Illuminator | Amico Diagnostic Incorporated | 2026-02-24 |
| 04053755202973 | FINOFF TRANSILLUMINATOR | Heine Optotechnik GmbH & Co. KG | 2025-07-17 |
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| 00732094074130 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 00732094082708 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 00732094074185 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 00732094074192 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 00732094082715 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 00732094082739 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-08-17 |
| 04260114140214 | ASTODIA | Stihler Electronic GmbH | 2023-07-18 |
| 00850018561099 | Wee Sight Transilluminator | INTERNATIONAL BIOMEDICAL, LTD. | 2023-06-20 |
| 00732094084207 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2023-04-25 |
| 04053755200429 | FINOFF TRANSILLUMINATOR | Heine Optotechnik GmbH & Co. KG | 2022-12-21 |
| 04053755120109 | OPHTHALMIC EXAMINATION LAMP | Heine Optotechnik GmbH & Co. KG | 2022-12-21 |
| 04053755119943 | OPHTHALMIC EXAMINATION LAMP | Heine Optotechnik GmbH & Co. KG | 2022-12-21 |
| 10812594013062 | NeoGlo Disposable | Neotech Products LLC | 2021-05-20 |
| 10812594013000 | NeoGlo Disposable | Neotech Products LLC | 2021-05-20 |
| 04719873921447 | LUMINDEX | DENTMATE TECHNOLOGY CO., LTD. | 2019-07-17 |
| 04719873921775 | LUMINDEX | DENTMATE TECHNOLOGY CO., LTD. | 2019-07-17 |
| 04719873921782 | LUMINDEX | DENTMATE TECHNOLOGY CO., LTD. | 2019-07-17 |