Headlamp, Operating, Battery-Operated
A Battery-Operated Operating Headlamp is a portable, wearable light source used by ophthalmic surgeons and clinicians to provide hands-free illumination directed at the operative field during surgical procedures or clinical examinations. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification or approval. It carries product code HPP and is regulated under 21 CFR 886.4335, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HPP
- Device Class
- FDA class 1
- Regulation Number
- 886.4335
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 71 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 71 registration numbers. Click on an entry to view related FDA registrations.