FDA 510(k)

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)

Numéro K : K221246 · 2022-07-07

DemandeurShenzhen Semlamp Intelligent Technology Co., Ltd.

Date de décision2022-07-07

Code produitOHT

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Semlamp Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K221246. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)?

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Shenzhen Semlamp Intelligent Technology Co., Ltd.. The 510(k) number is K221246.

When did IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) receive FDA 510(k) clearance?

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) received FDA 510(k) clearance on 2022-07-07, under 510(k) number K221246.

Who is the listed applicant for IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)?

The FDA 510(k) record lists Shenzhen Semlamp Intelligent Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)?

The FDA product code for IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is OHT.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Autres dossiers indiquant Shenzhen Semlamp Intelligent Technology Co., Ltd. en tant que demandeur

K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F)K240969IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328)

Dispositifs connexes (Code : OHT)

K261977Braun Aura 9 (6042)Cyden Limited K262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd.K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic Co., Ltd.K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.

Source officielle

Voir dans la base de données FDA →

Données issues de l'API ouverte de la FDA. Pour les informations les plus récentes et faisant autorité, veuillez toujours vous référer au registre officiel.