Skip to content
devi
CERTS
Devices
Categories
Manufacturers
Importers
Certifiers
Authorities
Reps.
Representatives
Categories
/
Medical equipment and related accessories, software and consumables
/
Instruments for functional explorations and therapeutic interventions
/
General medicine instruments
/
General medicine therapeutic treatment instruments
/
Phototherapy equipment
Phototherapy equipment
Z12040202
226 devices
Sheerwave
Active Optical Systems Ltd
·
,
Israel
Class IIa
CE/MDD
GUDID
on market
Celluma Series 2 PRO
BioPhotas, Inc.
·
,
United States
Class IIa
FDA 510(k)
×3
K171323
Active
Cleared 1 Sep 2017
CE/MDR
SAD Light
Zero-Plus International Limited
·
,
Hong Kong SAR China
Class IIa
CE/MDD
Bright Pad Pro
Zero-Plus International Limited
·
,
Hong Kong SAR China
Class IIa
CE/MDD
Celluma Series 2 CONTOUR PLUS
BioPhotas, Inc.
·
,
United States
Class IIa
FDA 510(k)
K232977
Active
Cleared 21 Nov 2023
CE/MDR
Medical Intense Pulsed Light Treatment System
Shandong Huamei Technology Co., Ltd.
·
,
China
Class IIb
FDA 510(k)
×2
K192521
Active
Cleared 6 Dec 2019
CE/MDD
Lumoral protective plastic cover
Koite Health Oy
·
,
Finland
Class I
CE/MDR
B.Light
Bemer Int. AG
·
,
Liechtenstein
Class IIa
CE/MDD
Trigger Point Laser
THOR Photomedicine Ltd
·
,
United Kingdom
Class IIb
CE/MDR
2026-MDR/QS-016
Active
Valid to Feb 2031
GUDID
on market
Esther
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
Medical Intense Pulsed Light Treatment System
Shandong Huamei Technology Co., Ltd.
·
,
China
Class IIb
CE/MDD
GUDID
on market
Shark CryoGlow
SharkNinja Operating LLC
·
,
United States
Class IIa
CE/MDR
Rex-Light
Ami Inc.
·
,
South Korea
Class IIa
CE/MDD
Intensive Care Phototherapy
Okuman Medikal Sistemler Anonim Sirketi
·
,
Türkiye
Class IIb
CE/MDD
Solaxel
Ids Ltd.
·
,
South Korea
Class IIb
CE/MDD
Celluma MYSTIQUE - EU
BioPhotas, Inc.
·
,
United States
Class IIa
CE/MDR
Skin Photodynamic Therapy Systems
Shanghai Apolo Medical Technology Co., Ltd
·
,
China
Class IIa
CE/MDD
GUDID
on market
Lumoral Clinic
Koite Health Oy
·
,
Finland
Class IIa
CE/MDR
FI25/00000056
Active
Valid to Oct 2028
Large LED Cluster
THOR Photomedicine Ltd
·
,
United Kingdom
Class IIb
CE/MDR
2026-MDR/QS-016
Active
Valid to Feb 2031
GUDID
on market
Saalux® UV Kamm (UVB 311nm) DE
Saalmann medical GmbH & Co. KG
·
,
Germany
Class IIa
CE/MDR
Previous
Next