FDA 510(k)

BioPhotas Celluma3

K号: K152280 · 2016-03-02

决定日期2016-03-02

产品代码ILY

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决定实质等同

器械摘要

BioPhotas Celluma3 is the device name listed in this FDA 510(k) record. The listed applicant is Biophotas, Inc.. It received FDA 510(k) clearance on 2016-03-02 under 510(k) number K152280. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BioPhotas Celluma3?

BioPhotas Celluma3 is a medical device that received FDA 510(k) clearance on 2016-03-02. The listed applicant is Biophotas, Inc.. The 510(k) number is K152280.

When did BioPhotas Celluma3 receive FDA 510(k) clearance?

BioPhotas Celluma3 received FDA 510(k) clearance on 2016-03-02, under 510(k) number K152280.

Who is the listed applicant for BioPhotas Celluma3?

The FDA 510(k) record lists Biophotas, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioPhotas Celluma3?

The FDA product code for BioPhotas Celluma3 is ILY.

列明Biophotas, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232977Biophotas Celluma CONTOUR K211038Biophotas Celluma RESTORE K171323BIOPHOTAS CELLUMA3

相关器械（代码：ILY）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253965CureLight 医疗二极管激光系统（CureLight F2-A15；CureLight F2-B15；CureLight F2-A30；CureLight F2-B30；CureLight F3-AB30；CureLight F3-AB60）Wuhan PHOMED Technology Company , Ltd.K242755医疗二极管激光系统（VELAS II-30B，VELAS II-30A，GBOX-15AB，GBOX-20B，CHEESE II-10B）Gigaalaser Company , Ltd.K231997SIRONA 100 治疗激光系统 (OEM的型号 EVANLAS)Cure Point Therapeutics, Inc.K223642LED唇部修护仪，型号：ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

官方来源

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