Eu Mdd Eu Md Class 2a On The Market ๐Ÿ‡บ๐Ÿ‡ธ United States

Celluma

BioPhotas, Inc. ยท ๐Ÿ‡บ๐Ÿ‡ธ United States
Devices (same UDI-DI)
1
Certificates
1
Countries
13
Notified Bodies
1

Basic Information

Primary DI
00850523007310
Basic UDI-DI Code
B-00850523007310
Reference
850523007310
Device Types
None provided
Regulation
Eu Mdd
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
BioPhotas, Inc.

Additional Description

The BioPhotas Celluma devices are intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm relieving stiffness promoting the relaxation of muscle tissue and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate acne vulgaris. The Celluma is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles and dermal wound healing.

CND Nomenclature Codes

Code Description
Z12040202 PHOTOTHERAPY EQUIPMENT

Certificates

Type Number
MDD Annex II (excluding section 4) CE 645104

Available In Countries

๐Ÿ‡ฆ๐Ÿ‡น Austria ๐Ÿ‡ง๐Ÿ‡ช Belgium ๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ณ๐Ÿ‡ฑ Netherlands ๐Ÿ‡ณ๐Ÿ‡ด Norway ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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