Loupe, Diagnostic/Surgical
A diagnostic and surgical loupe is a magnifying optical device worn over the eyes or attached to eyewear, used by surgeons and clinicians to magnify the operative or examination field for improved precision. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FSP, regulated under 21 CFR 878.4800, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- FSP
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- 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 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K895248 | IMS5000 ILLUMINATED LOUPES | Sep 15, 1989 | Substantially Equivalent | Luxtec Corp. |
| K891895 | SURGICAL LOUPES | Apr 12, 1989 | Substantially Equivalent | Zinnanti Surgical Instruments, Inc. |
| K864386 | LUXTEC LOUPES FOR SURGICAL VISION | Nov 17, 1986 | Substantially Equivalent | Luxtec Corp. |
| K861749 | 3X BLUE PANORAMIC LOUPES 13.5 WORKING DISTANCE | May 23, 1986 | Substantially Equivalent | Keeler Instruments, Inc. |
FEI Numbers
This FDA classification entry is associated with 60 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 60 registration numbers. Click on an entry to view related FDA registrations.