Product code FCT
- Device name
- Headlight, Fiberoptic Focusing
- 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 |
|---|---|---|---|
| K960767 | LIGHT COMMANDER | Scieran Technologies, Inc. | 1996-08-26 |
| K924198 | MODIFIED SITE FIBER OPTIC MODULE | Chiron Vision Corp. | 1992-11-23 |
| K883480 | MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE | Site Microsurgical Systems, Inc. | 1988-08-24 |
| K802769 | FIBER OPTIC HEADLIGHT #60-0765 | Aspen Laboratories, Inc. | 1980-12-11 |
| K802770 | FIBER OPTIC HEADLIGHT #60-0766766 | Aspen Laboratories, Inc. | 1980-12-11 |
| K780433 | FIBER OPTIC ADJUSTABLE HEADLIGHT | Cameron-Miller, Inc. | 1978-06-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860013851521 | Altair HI 2 | QED, INC. | 2025-05-21 |
| 00860013851538 | Altair SA | QED, INC. | 2025-05-21 |
| 00840183529192 | BR Surgical, LLC | BR Surgical, LLC | 2024-12-02 |
| 00840183500559 | BR Surgical, LLC | BR Surgical, LLC | 2024-07-22 |
| 00840183501136 | BR Surgical, LLC | BR Surgical, LLC | 2024-07-22 |
| 00840183512989 | BR Surgical, LLC | BR Surgical, LLC | 2024-07-22 |
| 00816835023974 | IsoLED Mini LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 01816835024062 | Magnum LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 01816835024055 | Magnum LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 01816835024031 | IsoLED Plus+ LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 01816835024024 | IsoLED Plus+ LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 01816835024017 | IsoLED Plus+ LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 01816835023997 | IsoLED II LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 01816835023980 | IsoLED II LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 01816835023973 | IsoLED Mini LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 01816835023966 | IsoLED Mini LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 00816835023950 | IsoLED Mini LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 00816835024063 | Magnum LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 00816835024056 | Magnum LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 00816835024032 | IsoLED Plus+ LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 00816835024025 | IsoLED Plus+ LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 00816835024018 | IsoLED Plus+ LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 00816835023998 | IsoLED II LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 00816835023981 | IsoLED II LED HL | Medical Illumination International Inc. | 2023-10-02 |
| 00816835023967 | IsoLED Mini LED HL | Medical Illumination International Inc. | 2023-10-02 |
| B366HDL200 | FIBEROPTIC HEADLUX | Ecleris | 2022-06-10 |
| 00862658000326 | Fiberoptics Technology Inc | FIBEROPTICS TECHNOLOGY, INC. | 2021-07-26 |
| 04055207008751 | NA | Richard Wolf GmbH | 2018-10-17 |
| M678HL0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2017-05-09 |
| M678HLM0 | Sunoptic Technologies | SUNOPTIC TECHNOLOGIES LLC | 2017-05-09 |