Who else makes this device?

Name: SilhouetteStar
Brand: SilhouetteStar

General & Plastic Surgery › SurgicalTape, Camera, Surgical

SilhouetteStar

SilhouetteStar™ is a non-contact device used to collect images, measurements and other information from all external wound types at the point of care; it is connected to a computer via a…

Registry build 21.09.26

SilhouetteStar™ is a non-contact device used to collect images, measurements and other information from all external wound types at the point of care; it is connected to a computer via a USB cable.

4manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (2), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code FXN
Manufacturer	City	Province	Registered as	Device types
Dongguan Hosscom Plastic Technology Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	1
Suzhou Texnet	Suzhou	Jiangsu	Contract manufacturer	47
Changzhou Major Medical Products Co., Ltd.	Changzhou	Jiangsu	Contract manufacturer	31
Guangdong Tidakang Medical Technology Co., Ltd.	Zhongshan	Guangdong	Manufacturer	12

Record

Regulatory record for SilhouetteStar
Listed by	Aranz Medical Limited, New Zealand
FDA product code	FXN
Device type	Tape, Camera, Surgical
Device class	Class 1
Regulation	21 CFR 878.4160
Premarket notification	Exempt
Record published	2024-04-03

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for SilhouetteStar
Catalogue number	Size	Status
2005.01		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Minuteful for Wound	Healthy.io Ltd.	2
Spot	Healthy.io Ltd.	2
SnapshotGLO	Kent Imaging Inc	1
Swift Vision	Swift Medical	1
Healogics Photo+	Swift Medical	1
MolecuLightDX+ Thermal Eco Clip	Moleculight Inc.	1
Tissue Analytics	Net Health Systems, Inc.	1
Thermal Imaging Module	Moleculight Inc.	1
eKare inSight	E-Kare Inc.	1
Minuteful for Wound at Home	Healthy.io Ltd.	1
PointClickCare Skin and Wound	Swift Medical	1
Medline NE1® WMS	Swift Medical	1

Showing 12 of 16. All products under Tape, Camera, Surgical

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K070426	2007-06-29

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.