Pad, Neonatal Eye
The Neonatal Eye Pad is a soft, opaque pad used to cover and protect the eyes of newborns receiving phototherapy for neonatal jaundice, shielding the retinas from intense therapeutic light. It is classified as FDA Class 1 (lowest risk) and is subject only to general controls. The product code is FOK, regulated under 21 CFR 880.5270 in the General Hospital specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- FOK
- Device Class
- FDA class 1
- Regulation Number
- 880.5270
- Medical Specialty
- General Hospital
- Review Panel
- HO
- 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 |
|---|---|---|---|---|
| K962290 | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER | Jul 03, 1996 | Substantially Equivalent | Debusk Technology Corp. |
| K926118 | LIFE TRACE(R) BILIRUBIN MASK | Mar 15, 1993 | Substantially Equivalent | Graphic Controls Corp. |
| K851918 | INFANT PHOTOTHERAPY MASK | Jun 07, 1985 | Substantially Equivalent | Alba Health Care |
| K840894 | PHOTO-THERAPY EYE PROTECTOR | Mar 23, 1984 | Substantially Equivalent | A & A Medical Supplies Co. |
| K813214 | INFANT PHOTOTHERAPY MASK | Dec 09, 1981 | Substantially Equivalent | Montrose Phototherapy Supply |
FEI Numbers
This FDA classification entry is associated with 27 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 27 registration numbers. Click on an entry to view related FDA registrations.