PLASMALUXLS
FDA 510(k) clearance K100628 · decided 2010-11-24
Clearance details
- K-number
- K100628
- Device name
- PLASMALUXLS
- Applicant
- Daavlin Distributing Co.
- Decision
- Substantially Equivalent
- Date received
- 2010-03-05
- Decision date
- 2010-11-24
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- ONE
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bryan, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.