Product code FSR
- Device name
- Light, Headband, Surgical
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4335
- 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 |
|---|---|---|---|
| K110528 | INTEGRA LED SURGICAL HEADLIGHT SYSTEM | Integra LifeSciences Corporation | 2011-05-11 |
| K031548 | LED HEADLIGHT | Welch Allyn, Inc. | 2003-08-11 |
| K031549 | SOLID STATE LAMP [LED] HEADLIGHT | Welch Allyn, Inc. | 2003-08-11 |
| K994362 | HEADLAMP HL2000. | Angiolaz, Inc. | 2000-05-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08404535020120 | Brasseler EZX | IMEDICOM CO., LTD. | 2025-10-10 |
| 00848657071017 | Light, Headband, Surgical | NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. | 2023-10-12 |
| 00732094004571 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2022-05-19 |
| 00732094004564 | Welch Allyn, Inc. | WELCH ALLYN, INC. | 2022-05-19 |
| 04048551124468 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551124444 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 10381780168638 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-09 |
| 10381780168720 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-09 |
| 10381780168768 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168669 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| M433905241 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| M433905231 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| M433905211 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| M43390520CS1 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168805 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168713 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168706 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168652 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168645 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168621 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-09-07 |
| 10381780168515 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168317 | Integra® | INTEGRA LIFESCIENCES (IRELAND) LIMITED | 2016-09-07 |
| 10381780168607 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-31 |
| 10381780168577 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-31 |
| H834905001 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-31 |
| H83490500W1 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-31 |
| 10381780168553 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-31 |
| 10381780168614 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-31 |
| 10381780168492 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-31 |
| 10381780168485 | Integra® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2016-08-31 |