FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MeDioStar
K Number: K192483
·
Decision Mar 13, 2020
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
20
Review Days
185
Basic Information
- Device Name
- MeDioStar
- K Number
- K192483
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- ASCLEPION LASER TECHNOLOGIES GMBH
- Date Received
- September 10, 2019
- Decision Date
- March 13, 2020
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by ASCLEPION LASER TECHNOLOGIES GMBH
| K Number | Device Name | ||
|---|---|---|---|
| K161257 | MultiPulse HoPLUS | Mar 31, 2017 | Substantially Equivalent |
| K152153 | MicroSpot Handpiece | Dec 11, 2015 | Substantially Equivalent |
| K150140 | MCL 31 Dermablate | Jun 5, 2015 | Substantially Equivalent |
| K143519 | The MeDioStar NeXT Family | Mar 10, 2015 | Substantially Equivalent |
| K133891 | MULTIPULSE TM+1470 | Jan 30, 2015 | Substantially Equivalent |
| K131987 | MULTIPULSE HOPLUS | Oct 15, 2014 | Substantially Equivalent |
| K131757 | TATTOOSTAR EFFECT COMBO | Jul 17, 2014 | Substantially Equivalent |
| K133297 | QUADROSTARPROGREEN, QUADROSTARPROYELLOW | Jun 10, 2014 | Substantially Equivalent |
| K113489 | ORION | Jul 27, 2012 | Substantially Equivalent |
| K112669 | TATTOOSTAR EFFECT Y | May 11, 2012 | Substantially Equivalent |