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.o.o.

Ljubljana, SI

FOTONA D.O.O. appears in FDA device records in Ljubljana, SI. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
16
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 16 510(k) clearances for Fotona d.o.o. between 2017 and 2025. The busiest year on record is 2020, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Fotona d.o.o., by decision year
YearClearances
20172
20181
20191
20203
20212
20222
20232
20242
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K241785StarFormer (M008-3T)QPLSubstantially Equivalent
K242202LightWalker Laser System FamilyGEXSubstantially Equivalent
K234061StarFormerKPISubstantially Equivalent
K221274StarFormer, TightWaveIPFSubstantially Equivalent
K223540AvalancheLase FamilyGEXSubstantially Equivalent
K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)GEXSubstantially Equivalent
K213267Dynamis Pro FamilyGEXSubstantially Equivalent
K202991Fotona XPulse Pro Laser PlatformGEXSubstantially Equivalent
K202985LightWalker Laser System FamilyGEXSubstantially Equivalent
K202172StarWalkerGEXSubstantially Equivalent
K193656SkyPulseGEXSubstantially Equivalent
K193661LightWalker Laser System FamilyGEXSubstantially Equivalent
K191554LightWalker Laser System FamilyGEXSubstantially Equivalent
K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroGEXSubstantially Equivalent
K172819LightWalker Laser System FamilyGEXSubstantially Equivalent
K171227StarWalkerGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Fotona d.o.o., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96134621000597018FOTONA D.O.O.STEGNE 7,, LJUBLJANA 1000 SI2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

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

Verification record

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