FDA 510(k) K004006, SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER, by Lumenis, Inc.
FDA 510(k) K004006, SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER, by Lumenis, Inc.
Device Classification Name: Powered Laser Surgical Instrument
510(k) Number: K004006
Device Name: SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
Applicant: Lumenis, Inc.
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 12/26/2000
Decision Date: 03/26/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
510k Review Panel: General & Plastic Surgery
Total number of pages: 834
Fully redacted pages: 215
Content pages: 619
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