FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
Therapy US
K Number: K252273
·
Decision Dec 12, 2025
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
53
Applicant Total
1
Review Days
143
Basic Information
- Device Name
- Therapy US
- K Number
- K252273
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dmc Importação E Exportação DE Equipamentos Ltda
- Date Received
- July 22, 2025
- Decision Date
- December 12, 2025
- Product Code
- NHN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| NHN | Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | FDA class 2 | Physical Medicine |
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