DEVICE: Standard 64 Tip,Fuse (100 Puls), Steril, SubRF (07290109950648)
Device Identifier (DI) Information
Standard 64 Tip,Fuse (100 Puls), Steril, SubRF
AS75106
In Commercial Distribution
AS75106
SYNERON MEDICAL LTD
AS75106
In Commercial Distribution
AS75106
SYNERON MEDICAL LTD
Standard 64 Tip,Fuse (100 Puls), Steril, SubRF
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Multi-modality skin surface treatment system | A 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | Electrosurgical, Cutting & Coagulation & Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K090025 | 000 |
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
525c454d-27de-4a8c-907f-f02bf25d4a45
July 06, 2018
3
September 26, 2016
July 06, 2018
3
September 26, 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 |
---|---|---|---|---|---|
37290109950649 | 10 | 07290109950648 | In Commercial Distribution |
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
[?]
No Customer Contact currently defined