SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
FDA 510(k) clearance K101306 · decided 2011-07-01
Clearance details
- K-number
- K101306
- Device name
- SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2A
- Applicant
- Fotona D.D.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-10
- Decision date
- 2011-07-01
- Days to decision
- 417 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Ljubljana, SI
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.