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

Washington, DC, US

Radiancy (Israel) , Ltd. appears in FDA device records in Washington, DC. FDA records list 11 510(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
11
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 11 510(k) clearances for Radiancy (Israel), Ltd. between 2002 and 2010. The busiest year on record is 2003, with 3. The most recent is 2010, with 1.

Clearances by year, as a table
510(k) clearance decisions for Radiancy (Israel), Ltd., by decision year
YearClearances
20021
20033
20051
20063
20082
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K102477NO!NO! SKINOLPSubstantially Equivalent
K082423NO!NO! SKINGEXSubstantially Equivalent
K072331RADIANCY MISTRAL DEVICEGEXSubstantially Equivalent
K060411RADIANCY CLEARTOUCH LITE ACNE CLEARANCE SYSTEMGEXSubstantially Equivalent
K052991RADIANCY FACIAL SKINCARE DEVICEGEXSubstantially Equivalent
K052442RADIANCY SKINSTATION WITH PSORIASIS LIGHT UNIT ASSEMBLYGEXSubstantially Equivalent
K051671RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLYGEXSubstantially Equivalent
K032205RADIANCY ACNE SYSTEM WITH CLEARTOUCH LIGHT UNIT ASSEMBLYGEXSubstantially Equivalent
K033181SPR SYSTEMGEXSubstantially Equivalent
K030897SKINSTATIONGEXSubstantially Equivalent
K020856SPATOUCH PHOTOEPILATION 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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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