Device class
Class II
Regulation 890.5500
Total clearances
11
2021-10-22 → 2026-05-19
Definition
What is Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. This device emits energy in the infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating. The classification regulation for infrared lamps describes a device that emits energy in the infrared wavelength to provide topical heating and that is not limited to adjunctive use.
Classification details
Medical specialty
Physical Medicine
Regulation number
890.5500
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Erchonia Corporation
|
5 |
1 |
2026-02-19 |
|
Multi Radiance Medical |
2 |
1 |
2026-05-19 |
|
Dmc Importação E Exportação DE Equipamentos Ltda |
1 |
1 |
2025-12-12 |
|
Ptech Co., Ltd. |
1 |
0 |
2022-02-11 |
|
Wuhan Guangdun Technology Co.,Ltd.. |
1 |
0 |
2025-01-24 |
|
Dmc Importacao E Exportacao DE Equipamentos Ltda |
1 |
0 |
2024-12-19 |
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 |
| 97012 |
CPT
|
— |
Medium
|
Modality treatment by physical medicine; laser/light modality for pain |
| E0621 |
HCPCS
|
Sling or seat, patient lift, canvas or nylon ✓ CMS-verified description |
Medium
|
Laser therapy device for pain management |
Pulse
Most recent 510(k) clearances