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FDA 510(k), K050216, OMNILUX REVIVE AND OMNILUX PLUS
FDA 510(k), K050216, OMNILUX REVIVE AND OMNILUX PLUS
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510(K) Number: K050216
Device Name: OMNILUX REVIVE AND OMNILUX PLUS
Manufacturer: PHOTO THERAPEUTICS LIMITED
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 01/31/2005
Decision Date: 08/09/2005
Regulation Medical Specialty: General & Plastic Surgery
Device Name: OMNILUX REVIVE AND OMNILUX PLUS
Manufacturer: PHOTO THERAPEUTICS LIMITED
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 01/31/2005
Decision Date: 08/09/2005
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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