Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name powered laser surgical instrument
510(k) Number K902470
Device Name COHERENT XA30/SP AND XA50 SURGICAL LASERS
Applicant
LUMENIS, INC.
3270 WEST BAYSHORE RD.
Marlborough,  MA  01752
Applicant Contact Donna M Gardner
Correspondent
LUMENIS, INC.
100 Boston Scientific Way
Marlborough,  MA  01752
Correspondent Contact Donna M Gardner
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/04/1990
Decision Date 07/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-