Accessories To Examination Light
The Accessories to Examination Light are general hospital devices that attach to clinical examination lights and assist in magnifying, clarifying, or enhancing the image being viewed during physical examination or minor procedures. They fall under the General Hospital medical specialty and are classified as a Class 1 device under regulation 880.6320, subject to general controls only with a low regulatory burden. These accessories expand the diagnostic utility of standard examination lights. They are not implants and are not life-sustaining.
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Basic Information
- Product Code
- PEQ
- Device Class
- FDA class 1
- Regulation Number
- 880.6320
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
Definition
Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K131338 | DERMA HOOD | Jul 10, 2013 | Substantially Equivalent | Globalmedia Group, LLC |
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.