Lamp, Operating-Room
An operating room lamp is a high-intensity lighting fixture used to illuminate the surgical field during operative procedures. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires a 510(k) premarket notification before marketing. The product code is FQP, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FQP
- Device Class
- FDA class 2
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- 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 |
|---|---|---|---|---|
| K001223 | ACULUX, MODEL AX3001, AX3002 | Jun 23, 2000 | Substantially Equivalent | Aculux |
| K993314 | SYNTHES LIGHT GUIDE | Dec 06, 1999 | Substantially Equivalent | Synthes (Usa) |
| K781581 | SURGICAL LIGHT 22 SERIES | Oct 17, 1978 | Substantially Equivalent | American Sterilizer Co. |
| K770812 | HANDLES, LIGHT, SURGICAL, STEOILE | May 23, 1977 | Substantially Equivalent | Sybron Corp. |
| K761018 | SURGICAL LIGHT - CHALLENGE 22 SERIES | Jan 26, 1977 | Substantially Equivalent | Amsco Co. |
FEI Numbers
This FDA classification entry is associated with 37 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 37 registration numbers. Click on an entry to view related FDA registrations.