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

Tel Aviv, IL

POLLOGEN LTD appears in FDA device records in Tel Aviv, IL. FDA records list 18 510(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
18
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 18 510(k) clearances for Pollogen Ltd between 2011 and 2025. The busiest year on record is 2024, with 3. The most recent is 2025, with 3.

Clearances by year, as a table
510(k) clearance decisions for Pollogen Ltd, by decision year
YearClearances
20111
20132
20141
20171
20181
20191
20212
20221
20232
20243
20253
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242227GENEO X ELITEPAYSubstantially Equivalent
K252576Legend X PlatformGEISubstantially Equivalent
K250734OptiLUV DevicePBXSubstantially Equivalent
K243217Legend X Desktop SystemGEISubstantially Equivalent
K240999Legend X Applicator VOGEISubstantially Equivalent
K233766Geneo X ElitePAYSubstantially Equivalent
K232903Legend X PlatformGEISubstantially Equivalent
K220322Pollogen STOP U Model UXV DevicePAYSubstantially Equivalent
K220124YandR System, VoluDerm Handpiece, VoluDerm TipsGEISubstantially Equivalent
K200545Legend Pro DMANGXSubstantially Equivalent
K203665STOP U Model UXV DevicePAYSubstantially Equivalent
K182774STOP U (Packed Black USA), STOP U (Packed White USA)PAYSubstantially Equivalent
K173503Pollogen Legend SystemGEISubstantially Equivalent
K171359Pollogen Legend+ SystemGEISubstantially Equivalent
K140255STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)GEISubstantially Equivalent
K131758SURGEN UGEISubstantially Equivalent
K122200A3F FRATIONALGEISubstantially Equivalent
K111026APOLLOGEISubstantially Equivalent

Registered establishments

FDA registered establishments for Pollogen Ltd, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30087532753008753275POLLOGEN LTD6 Kaufman Street (main), Tel Aviv 6801298 IL2026

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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What MDM checks, and what it does not

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