FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
K Number: K251298
·
Decision Sep 4, 2025
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
6
Applicant Total
6
Review Days
129
Basic Information
- Device Name
- Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
- K Number
- K251298
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clinical Laserthermia Systems, AB
- Date Received
- April 28, 2025
- Decision Date
- September 4, 2025
- Product Code
- ONO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| ONO | Neurosurgical Laser With Mr Thermography | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
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Other Clearances by Clinical Laserthermia Systems, AB
| K Number | Device Name | ||
|---|---|---|---|
| K214125 | TRANBERG Thermoguide Therapy System | Sep 22, 2022 | Substantially Equivalent |
| K201466 | Tranberg CLS Laser Applicator | Mar 26, 2021 | Substantially Equivalent |
| K163103 | Tranberg CLS Diffusor Laser Fiber | Mar 23, 2017 | Substantially Equivalent |
| K151569 | Tranberg CLS Laser Fiber | Feb 12, 2016 | Substantially Equivalent |
| K142216 | Tranberg CLS Thermal Therapy System | Apr 21, 2015 | Substantially Equivalent |