BCLEAR

Light, Ultraviolet, Dermatological

LUMENIS, INC.

The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Bclear.

Pre-market Notification Details

• Device ID: K021762
• 510k Number: K021762
• Device Name: BCLEAR
• Classification: Light, Ultraviolet, Dermatological
• Applicant: LUMENIS, INC. 1249 QUARRY LN., SUITE 100 Pleasanton, CA 94566
• Contact: C. Robert Payne, Jr.
• Correspondent: C. Robert Payne, Jr.; LUMENIS, INC. 1249 QUARRY LN., SUITE 100 Pleasanton, CA 94566
• Product Code: FTC
• CFR Regulation Number: 878.4630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-29
• Decision Date: 2002-08-23
• Summary: summary