Headlamp, Operating, Ac-Powered
An AC-Powered Operating Headlamp is a mains-powered, wearable illumination device used by surgeons to provide focused, hands-free lighting during ophthalmic surgical and clinical examination procedures, offering sustained high-intensity illumination compared to battery-powered alternatives. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HPQ and is regulated under 21 CFR 886.4335, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HPQ
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K952289 | WELCH ALLYN FIBER OPTIC HEADLIGNT | Jul 14, 1995 | Substantially Equivalent | Welch Allyn, Inc. |
| K951337 | FIBER HEAD LIGHT FH-300 | Jun 08, 1995 | Substantially Equivalent | Neitz Instruments Company, Ltd. |
| K861747 | KEELER FIBEROPTIC HEADLAMP | Aug 21, 1986 | Substantially Equivalent | Keeler Instruments, Inc. |
| K861746 | KEELER DUAL LIGHTSOURCE | Aug 21, 1986 | Substantially Equivalent | Keeler Instruments, Inc. |
| K822272 | HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS | Nov 10, 1982 | Substantially Equivalent | Kelleher Corp. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.