Device class
Class II
Regulation 882.5970
Total clearances
4
2021-04-27 → 2025-03-17
Definition
What is Orthosis, Cranial, Laser Scan
A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A laser scanning accessory may be used to create a scan of the infant's head. Indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Classification details
Medical specialty
Neurology
Regulation number
882.5970
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
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 |
| L3000 |
HCPCS
|
Foot, insert, removable, molded to patient model, 'ucb' type, berkeley shell, each ✓ CMS-verified description |
High
|
Cranial orthosis, custom-fabricated; standard HCPCS for cranial shaping device |
| 20999 |
CPT
|
— |
Medium
|
Unlisted orthotic/orthopedic procedure code for cranial orthosis device |
Pulse
Most recent 510(k) clearances