Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Fotona D.D. — Predicate Candidate Screening

27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

108 daysmedian FDA review time

308 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K143723	SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro	Fotona D.D.	2015-04-09	101
K132806	FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER H	Fotona D.D.	2014-07-11	308
K121508	LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER S	Fotona D.D.	2012-12-12	205
K113702	FOTONA XP ND: YAG LASER SYSTEM	Fotona D.D.	2012-03-28	103
K101306	SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS,	Fotona D.D.	2011-07-01	417
K101817	LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021	Fotona D.D.	2010-11-22	145
K093162	FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS P	Fotona D.D.	2010-01-22	108
K090126	FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS	Fotona D.D.	2009-06-29	159
K083889	FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY	Fotona D.D.	2009-04-23	115
K083034	FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2F	Fotona D.D.	2009-02-04	117
K070355	FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILY	Fotona D.D.	2008-03-04	392
K053139	FOTONA QX ND:YAG/KTP LASER SYSTEM	Fotona D.D.	2006-02-16	99
K050293	FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUAL	Fotona D.D.	2005-03-18	39
K024204	FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM	Fotona D.D.	2003-07-07	199
K021548	FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEM	Fotona D.D.	2002-12-06	207
K022838	FOTONA DUALIS ER:YAG/KTP LASER SYSTEM	Fotona D.D.	2002-11-25	90
K022839	FOTONA DUALIS PLUS ND:YAG LASER SYSTEM	Fotona D.D.	2002-11-25	90
K022837	FOTONA TANDEM LASER SYSTEM	Fotona D.D.	2002-11-25	90
K011939	FOTONA DUALIS, FOTONA DUALIS PLUS	Fotona D.D.	2001-12-27	189
K011174	PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSO	Fotona D.D.	2001-11-07	204
K002884	PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIES	Fotona D.D.	2000-12-04	80
K001527	FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIES	Fotona D.D.	2000-07-27	72
K000106	DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIES	Fotona D.D.	2000-04-18	96
K991634	FOTONA NOVALIS R RUBY LASER SYSTEM	Fotona D.D.	1999-08-10	90
K991632	FOTONA NOVALIS ER: YAG LASER SYSTEM	Fotona D.D.	1999-08-10	90
K990243	FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIES	Fotona D.D.	1999-06-09	135
K980560	FOTONA SKINPLUS LASER SYSTEM	Fotona D.D.	1998-03-27	42

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda