MICRODERM, MODEL/VERSION 3.5
FDA 510(k) clearance K040171 · decided 2004-06-08
Clearance details
- K-number
- K040171
- Device name
- MICRODERM, MODEL/VERSION 3.5
- Applicant
- Visiomed AG
- Decision
- Substantially Equivalent
- Date received
- 2004-01-26
- Decision date
- 2004-06-08
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- PSN
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- South West Ranches, FL, US
- Third-party review
- No
- Expedited review
- No
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| SIASCOPE V (K062736) | Astron Clinica Limited | 2007-09-14 |
| SIASCOPE II (K023729) | Astron Clinica Limited | 2003-02-03 |
| SI ASCOPE (K011273) | Astron Clinica Limited | 2002-02-20 |
Recalls involving this device
No recalls on record reference this clearance.