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510(k) Data Aggregation
K Number
K231948Device Name
MEDIYAG
Manufacturer
Medicreations LLC
Date Cleared
2024-10-09
(467 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Medicreations LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MediYag is indicated for:
532nm wavelength: treatment of benign pigmented lesions (Lentigines, Birthmark: Cafe-Au-Lait).
1064nm wavelength: treatment of acne scars, benign pigmented lesions (Nevus of Ota), and removal of dark ink tattoos (black, blue).
Device Description
The MediYag is a laser system which delivers a laser at a wavelength of 1064nm or 532nm.
Component Name | Function
---|---
Main Unit | Main human-machine interface
Articulated Arm | Articulated arm for holding of Treatment Probe
Treatment Probe | Laser Delivery
Foot Pedal | Control light output
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K Number
K231950Device Name
MEDIDIODE
Manufacturer
Medicreations LLC
Date Cleared
2024-08-09
(406 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Medicreations LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MediDiode is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hair regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Description
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