DEVICE: SapphireCool Light Guide 6 mm (07290109140995)
Device Identifier (DI) Information
SapphireCool Light Guide 6 mm
SapphireCool Light Guide 6 mm
Not in Commercial Distribution
LUMENIS LTD.
SapphireCool Light Guide 6 mm
Not in Commercial Distribution
LUMENIS LTD.
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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GEX | Powered Laser Surgical Instrument |
ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output |
ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
cbdab0cc-bdd1-44c8-9e5d-8d427cb8aa48
August 16, 2023
7
August 24, 2016
August 16, 2023
7
August 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
408-764-3000
xxx@xxx.xxx
xxx@xxx.xxx