Illuminator, Non-Remote
A non-remote illuminator is a lighting device used in surgical settings where the light source and the point of illumination are in close proximity, providing direct illumination without remote fiber optic transmission. 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 FTF, regulated under 21 CFR 878.4580, within the General, Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- FTF
- Device Class
- FDA class 2
- Regulation Number
- 878.4580
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
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 |
|---|---|---|---|---|
| K041621 | LITEPORT LP100 SURGICAL ILLUMINATOR | Sep 13, 2004 | Substantially Equivalent | Medical Vision Industries, Inc. |
| K840373 | FLEXIBLE ILLUMINATOR 10 | Apr 24, 1984 | Substantially Equivalent | Suncoast Medical Manufacturers, Inc. |
| K840372 | FLEXIBLE ILLUMINATOR 15 | Apr 24, 1984 | Substantially Equivalent | Suncoast Medical Manufacturers, Inc. |
| K840371 | FLEXIBLE ILLUMINATOR 5 | Apr 24, 1984 | Substantially Equivalent | Suncoast Medical Manufacturers, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.