PULSTAR

Powered Laser Surgical Instrument

LASERMED, INC.

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

Pre-market Notification Details

• Device ID: K992061
• 510k Number: K992061
• Device Name: PULSTAR
• Classification: Powered Laser Surgical Instrument
• Applicant: LASERMED, INC. 8050 SOUTH 1300 WEST West Jordan, UT 84088
• Contact: Calvin D Ostler
• Correspondent: Calvin D Ostler; LASERMED, INC. 8050 SOUTH 1300 WEST West Jordan, UT 84088
• Product Code: GEX
• CFR Regulation Number: 878.4810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-06-18
• Decision Date: 1999-07-30