FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
K Number: K251308
·
Decision Jan 15, 2026
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
1
Review Days
262
Basic Information
- Device Name
- SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
- K Number
- K251308
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thera B Medical Products
- Date Received
- April 28, 2025
- Decision Date
- January 15, 2026
- Product Code
- LBI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | FDA class 2 | General Hospital |
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