DEVICE: Extra (07290016727043)

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Device Identifier (DI) Information
Extra
818
In Commercial Distribution

ACTIVE OPTICAL SYSTEMS LTD
07290016727043
GS1

1
533637385 *Terms of Use
Hair removal device
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45220 Multi-modality skin surface treatment system
An electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] 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 energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K050950 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 500 and 1060 millibar
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Humidity: between 0 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
f849313a-3f17-41a1-a821-c2fdc1db3a08
February 03, 2023
4
October 11, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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