Product code HOG
- Device name
- Burr, Corneal, Battery-Powered
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4070
- 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 |
|---|---|---|---|
| K962989 | AMOILS EPITHELIAL SCRUBBER | S. Percy Amoils | 1997-01-09 |
| K960261 | PALLIKARIS BRUSH | Alcon Laboratories, Inc. | 1996-03-11 |
| K950520 | BURR, CORNEAL, BATTERY-POWERED | Aaron Medical Industries | 1995-05-02 |
| K883785 | GY-RO SAFE | Gy-Ro Industry, Inc. | 1989-01-05 |
| K834354 | OPHTEC RUST RING REMOVER | Jedmed Instrument Co. | 1984-03-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00628693343244 | Amoils Epithelial Scrubber | Innovative Excimer Solutions | 2025-02-28 |
| 00628693343237 | Amoils Epithelial Scrubber | Innovative Excimer Solutions | 2025-02-28 |
| 00628693343251 | Amoils Epithelial Scrubber | Innovative Excimer Solutions | 2025-02-28 |
| 00628693343268 | Amoils Epithelial Scrubber | Innovative Excimer Solutions | 2025-02-28 |
| 00628693343091 | Amoils Epithelial Scrubber | Innovative Excimer Solutions | 2024-10-31 |
| 00628693343107 | Amoils Epithelial Scrubber | Innovative Excimer Solutions | 2024-10-31 |
| 10887482177522 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 10887482177546 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-28 |
| 00887482177556 | Bovie | SYMMETRY SURGICAL INC. | 2024-08-28 |
| 00887482177532 | Bovie | SYMMETRY SURGICAL INC. | 2024-08-28 |
| 00887482176795 | Bovie | ASPEN SURGICAL PRODUCTS, INC. | 2024-08-27 |
| 00628693343039 | Amoils Epithelial Scrubber | Innovative Excimer Solutions | 2022-12-01 |
| 00628693343046 | Amoils Epithelial Scrubber | Innovative Excimer Solutions | 2022-12-01 |
| 00628693343053 | Amoils Epithelial Scrubber | Innovative Excimer Solutions | 2022-12-01 |
| 00841668120057 | Burr | KATENA PRODUCTS, INC. | 2022-11-16 |
| 00841668120064 | Burr | KATENA PRODUCTS, INC. | 2022-11-16 |
| 00886158010012 | Ophtho-Burr® | Beaver-Visitec International, Inc. | 2022-01-19 |
| 30886158010037 | Ophtho-Burr® | Beaver-Visitec International, Inc. | 2022-01-19 |
| 00192896012721 | ALGERBRUSH II HANDLE | SONTEC INSTRUMENTS, INC. | 2018-09-18 |
| 00192896012707 | ALGERBRUSH II PTERYGIUM BURR | SONTEC INSTRUMENTS, INC. | 2018-09-18 |
| 00192896012684 | ALGERBRUSH II PTERYGIUM BURR | SONTEC INSTRUMENTS, INC. | 2018-09-18 |
| 00192896012646 | ALGERBRUSH DIAMOND FINE GRIT BURR | SONTEC INSTRUMENTS, INC. | 2018-09-18 |
| M220P2121505 | Pro Advantage | NATIONAL DISTRIBUTION & CONTRACTING, INC. | 2017-02-13 |
| 10607151000124 | BOVIE | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-10 |
| 10607151000117 | BOVIE | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-10 |
| 10607151000100 | BOVIE | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-10 |
| 00607151012052 | BOVIE | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-10 |
| 00607151012014 | BOVIE | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-10 |
| 00607151000073 | BOVIE | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-10 |
| 00607151000011 | BOVIE | ASPEN SURGICAL PRODUCTS, INC. | 2016-10-10 |