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MEDIYAG

Medicreations, LLC

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

Medicreations, LLC
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K231948
Device name
MEDIYAG
Company
Medicreations, LLC
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-06-30
Decision date
2024-10-09
Submission type
Special
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentAcne treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for 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, Nevus of Ota), and removal of dark ink tattoos (black, blue).

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, 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. Main components include: Main Unit - Main human-machine interface; Articulated Arm - Articulated arm for holding of Treatment Probe; Treatment Probe - Laser Delivery; Foot Pedal - Control light output.

Summary parsed at:2026-06-01 05:26:25 UTC

Predicate devices

2

K231948 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K231948 as a predicate