Device class
Class II
Regulation 880.5700
Total clearances
4
2020-10-05 → 2026-01-15
Classification details
Medical specialty
General Hospital
Regulation number
880.5700
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Avalon Biomedical (Shenzhen) Limited |
1 |
0 |
2020-10-05 |
|
Thera B Medical Products |
1 |
1 |
2026-01-15 |
|
Bistos Co., Ltd.
|
1 |
0 |
2021-05-28 |
|
Gerium Medical, Ltd. |
1 |
0 |
2025-05-29 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| E1372 |
HCPCS
|
Immersion external heater for nebulizer ✓ CMS-verified description |
High
|
Phototherapy equipment for neonatal use, standard HCPCS code for neonatal phototherapy unit |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-01-15 |
K251308 |
Thera B Medical Products
|
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) |
| 2025-05-29 |
K243372 |
Gerium Medical, Ltd.
|
BiliWrap |
| 2021-05-28 |
K210289 |
Bistos Co., Ltd.
|
Infant Phototherapy Equipment |
| 2020-10-05 |
K200031 |
Avalon Biomedical (Shenzhen) Limited
|
Neonatal Phototherapy System |