Top Epil Classic

Primary DI
07290016727074
Brand
Top Epil Classic
Company
ACTIVE OPTICAL SYSTEMS LTD
Model
1
Device description
Epilation device
Published
2016-10-11
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
KCWEpilator, High Frequency, Needle-Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCWEpilator, High Frequency, Needle-TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016727074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016727074072900167270747290016727074

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 Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure500 millibar1060 millibar
Storage Environment Humidity0 Percent (%) Relative Humidity80 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
07290016727036Body ShapeRF-311N2017-01-09
07290016727043Extra 8182016-10-11
07290016727050Sheerwave3602016-10-11
07290016727067Optima5182016-10-11
07290016727081Crystal5122018-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08800016903317Secret RF Smartcure Applicator With ElectrodesCLASSYS Inc.KCW2024-10-30
00686209051014Pro-TecDectro InternationalKCW2024-10-09
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00686209051045Pro-TecDectro InternationalKCW2024-10-09
00686209051052Pro-TecDectro InternationalKCW2024-10-09
00686209052011Pro-TecDectro InternationalKCW2024-10-09
00686209052028Pro-TecDectro InternationalKCW2024-10-09
00686209052035Pro-TecDectro InternationalKCW2024-10-09
00686209052042Pro-TecDectro InternationalKCW2024-10-09
00686209052059Pro-TecDectro InternationalKCW2024-10-09
00686209052110Pro-TecDectro InternationalKCW2024-10-09
00686209052127Pro-TecDectro InternationalKCW2024-10-09
00686209052134Pro-TecDectro InternationalKCW2024-10-09
00686209052141Pro-TecDectro InternationalKCW2024-10-09
00686209052158Pro-TecDectro InternationalKCW2024-10-09
00686209100903ApilusDectro InternationalKCW2024-05-23
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00686209101115ApilusDectro InternationalKCW2024-05-23
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00686209106059ApilusDectro InternationalKCW2024-05-23
00686209101238ApilusDectro InternationalKCW2024-05-22
00850057194005Elegance+Clareblend, Inc.KCW2023-12-14
00850057194036EleganceClareblend, Inc.KCW2023-12-14
00850057194043G-TechClareblend, Inc.KCW2023-12-14
00850057194050EssenceClareblend, Inc.KCW2023-12-14
00850057194067EZ3Clareblend, Inc.KCW2023-12-14