International safety notice
Common names: (1) dye laser, (2) and (5) alexandrite laser, (3) xenon phototherapy device, (4) Cold therapy equipment and equipment Brand name: (1) Laser device for treatment of benign skin vascular lesions Cynergy J (2) Accolade J, a device for treating benign pigmented skin diseases (3) Icon (4) Cryo 6 (5) PicoSure device for treating benign pigmented skin diseases
Japan / PMDA Recalls · JPN · Dec 13, 2022
Key facts
| Regulator | Japan / PMDA Recalls |
|---|---|
| Country | JPN |
| Brand | Common names: (1) dye laser, (2) and (5) alexandrite laser, (3) xenon phototherapy device, (4) Cold therapy equipment and equipment Brand name: (1) Laser device for treatment of benign skin vascular lesions Cynergy J (2) Accolade J, a device for treating benign pigmented skin diseases (3) Icon (4) Cryo 6 (5) PicoSure device for treating benign pigmented skin diseases |
| Manufacturer | Cynosure Co., Ltd. |
| Models | 5-4063，25-4077，25-4114，25-4206，25-4207，25-4204, 19679852-16，19974565-07，19974566-06，19974566-07，19974566-08，19974567-0, 3，1620008624，1620008625，1620008626，1620008627，1720001247，1720001249，1720003514，1720003515，1, 25-1486，25-1507，25-1648，25-1754，25-1791，25-1792，25-1881，25-1884，25-1, 6，1920006997，1920006998，1920007458，1920007459，1920007460，1920009602，1920009603，1920009604，1, HP0481，VSHP0484，VSHP0486，VSHP0491，VSHP0492，VSHP0495, 59，25-2161，25-2162，25-2163，25-2165，25-2168，25-2174，25-2175，25-2535，25-2537，25-2656，25-265, 20932459-01，20932459-02，20932459-04，20932459-05, 720003516，1720003517，1720013837，1720013838，1720013839，1820005263，1820005264，1820005265，18200, 920016102，1920016103，1920016104，2020008985，2020008986，2020008987，2020008988，2020013360，20200, 30-06，21126460-05，21126460-07，21126460-12, 566-08，19974567-06，19974567-07，19974567-08 and 22 more |
| Date | Dec 13, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1