FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
K Number: K231997
·
Decision Oct 15, 2024
Classifications
1
FEI Numbers
423
Registration Numbers
423
Same Product Code
227
Applicant Total
1
Review Days
468
Basic Information
- Device Name
- SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
- K Number
- K231997
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cure Point Therapeutics, Inc.
- Date Received
- July 5, 2023
- Decision Date
- October 15, 2024
- Product Code
- ILY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
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