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FDA 510(k), K140388, LUMENIS PULSE 120H
FDA 510(k), K140388, LUMENIS PULSE 120H
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510(K) Number: K140388
Device Name: LUMENIS PULSE 120H
Manufacturer: LUMENIS LTD.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 02/14/2014
Decision Date: 03/14/2014
Regulation Medical Specialty: General & Plastic Surgery
Device Name: LUMENIS PULSE 120H
Manufacturer: LUMENIS LTD.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 02/14/2014
Decision Date: 03/14/2014
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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