510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Fotona D.D.

Ljubljana, SI

Fotona D.D. appears in FDA device records in Ljubljana, SI. FDA records list 27 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
27
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 27 510(k) clearances for Fotona D.D. between 1998 and 2015. The busiest year on record is 2002, with 4. The most recent is 2015, with 1.

Clearances by year, as a table
510(k) clearance decisions for Fotona D.D., by decision year
YearClearances
19981
19993
20003
20012
20024
20031
20051
20061
20081
20093
20102
20111
20122
20141
20151
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroGEXSubstantially Equivalent
K132806FOTONA F-22 LASER HANDPIECE (F-RUNNER), FOTONA FS-01 LASER HANDPIECEGEXSubstantially Equivalent
K121508LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-NPDZSubstantially Equivalent
K113702FOTONA XP ND: YAG LASER SYSTEMPDZSubstantially Equivalent
K101306SP DYNAMIS, SP SPECTRO, XS DYNAMIS, XS SPECTRO, XP DYNAMIS, XP SPECTRO, MODELS M021-4AF/3, M002-2AGEXSubstantially Equivalent
K101817LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-NGEXSubstantially Equivalent
K093162FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FIDGEXSubstantially Equivalent
K090126FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,GEXSubstantially Equivalent
K083889FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILYGEXSubstantially Equivalent
K083034FOTONA XD-2 DIODE LASER SYSTEM, MODEL MD01-2FGEXSubstantially Equivalent
K070355FOTONA FIDELIS III ER:YAG/ND:YAG LASER SYSTEM FAMILYGEXSubstantially Equivalent
K053139FOTONA QX ND:YAG/KTP LASER SYSTEMGEXSubstantially Equivalent
K050293FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMSGEXSubstantially Equivalent
K024204FOTONA FIDELIS PLUS ND:YAG LASER SYSTEMGEXSubstantially Equivalent
K021548FOTONA DUALIS ND:YAG/ER:YAG LASER SYSTEMGEXSubstantially Equivalent
K022839FOTONA DUALIS PLUS ND:YAG LASER SYSTEMGEXSubstantially Equivalent
K022838FOTONA DUALIS ER:YAG/KTP LASER SYSTEMGEXSubstantially Equivalent
K022837FOTONA TANDEM LASER SYSTEMGEXSubstantially Equivalent
K011939FOTONA DUALIS, FOTONA DUALIS PLUSGEXSubstantially Equivalent
K011174PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIESGEXSubstantially Equivalent
K002884PARADIGM-FOTONA YAPLASE ND:YAP LASER SYSTEM AND ACCESSORIESGEXSubstantially Equivalent
K001527FOTONA FIDELIS ER: YAG LASER SYSTEM AND ACCESORIESGEXSubstantially Equivalent
K000106DEPILASE YAGLASE ND:YAG LASER SYSTEM AND ACCESSORIESGEXSubstantially Equivalent
K991634FOTONA NOVALIS R RUBY LASER SYSTEMGEXSubstantially Equivalent
K991632FOTONA NOVALIS ER: YAG LASER SYSTEMGEXSubstantially Equivalent
K990243FOTONA FIDELIS ER:YAG LASER SYSTEM & ACCESSORIESGEXSubstantially Equivalent
K980560FOTONA SKINPLUS LASER SYSTEMGEXSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain