EPI-C PLUS— 510(k) K070494
Substantially EquivalentEspansione Marketing S.P.A
FDA 510(k) clearance K070494 for EPI-C PLUS, Substantially Equivalent on 2007-05-01. Applicant: Espansione Marketing S.P.A. Device class: 2.
Clearance details
- Applicant
- Espansione Marketing S.P.A
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- S. Lazzaro Di Savena, Bologna, IT
Recent devices under product code GEX
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- K261841 — Q Switched Nd:YAG Laser machine (QLQW-01)
- K261221 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
More clearances from Espansione Marketing S.P.A
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.