Light, Headband, Surgical
A headband surgical light is a wearable, hands-free lighting device mounted on a headband, used in surgical and clinical settings to direct illumination precisely where the clinician is looking. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FSR, regulated under 21 CFR 886.4335, within the Ophthalmic medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FSR
- Device Class
- FDA class 2
- Regulation Number
- 886.4335
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K110528 | INTEGRA LED SURGICAL HEADLIGHT SYSTEM | May 11, 2011 | Substantially Equivalent | Integra LifeSciences Corporation |
| K031549 | SOLID STATE LAMP [LED] HEADLIGHT | Aug 11, 2003 | Substantially Equivalent | Welch Allyn, Inc. |
| K031548 | LED HEADLIGHT | Aug 11, 2003 | Substantially Equivalent | Welch Allyn, Inc. |
| K994362 | HEADLAMP HL2000. | May 11, 2000 | Substantially Equivalent | Angiolaz, Inc. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.