Fotona D.D. is one of 8 FDA 510(k) medical device manufacturers from Slovenia in the dataset, ranked by real submission volume.
Fotona D.D. - FDA 510(k) Cleared Devices
27
Total
27
Cleared
0
Denied
Fotona D.D. has 27 FDA 510(k) cleared general & plastic surgery devices. Based in Ljubljana, SI.
Historical record: 27 cleared submissions from 1998 to 2015.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
Fotona D.D. — FDA 510(k) Products and Clearance History
27 devices
Cleared
Apr 09, 2015
SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro
General & Plastic Surgery
101d
Cleared
Jul 11, 2014
FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECE
General & Plastic Surgery
308d
Cleared
Dec 12, 2012
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
General & Plastic Surgery
205d
Cleared
Mar 28, 2012
FOTONA XP ND: YAG LASER SYSTEM
General & Plastic Surgery
103d
Cleared
Jul 01, 2011
SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO,...
General & Plastic Surgery
417d
Cleared
Nov 22, 2010
LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2,...
General & Plastic Surgery
145d
Cleared
Jan 22, 2010
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT...
General & Plastic Surgery
108d
Cleared
Jun 29, 2009
FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP...
General & Plastic Surgery
159d
Cleared
Apr 23, 2009
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY
General & Plastic Surgery
115d
Cleared
Feb 04, 2009
FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F
General & Plastic Surgery
117d
Cleared
Mar 04, 2008
FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY
General & Plastic Surgery
392d
Cleared
Feb 16, 2006
FOTONA QX ND:YAG/KTP LASER SYSTEM
General & Plastic Surgery
99d