FDA.reportPublic FDA data

Body Shape

Primary DI
07290016727036
Brand
Body Shape
Company
ACTIVE OPTICAL SYSTEMS LTD
Model
RF-311N
Device description
Exercise skin muscle equipment
Published
2017-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
BXBExerciser, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXBExerciser, PoweredPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016727036PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016727036072900167270367290016727036

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure700 millibar1060 millibar
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533637385
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016727012Spirit9182016-08-02
07290016727029Spirit9162016-08-02
07290016727043Extra 8182016-10-11
07290016727050Sheerwave3602016-10-11
07290016727067Optima5182016-10-11
07290016727074Top Epil Classic12016-10-11
07290016727081Crystal5122018-01-29

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