Manufacturer
Medicreations, LLCMEDIYAG
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
2ND YAG Q-switch Laser Therapy Machine
Nd: YAG Laser Therapy Systems
K231948 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K231948 as a predicate