# K193266: MIIN

- Pathway: 510(k) (Traditional)
- Applicant: Medico USA, Inc.
- Decided: Jan 22, 2021 after 423 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 269 ancestors in all.
No later device cites it as a predicate yet.
0 of 270 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133254: Revlite Q-Switched ND:Yag Laser System, Cynosure, Inc. (2014) Summary page 4.

## Indications for use
MIIN, Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in incision, excision, ablation, vaporization of soft tissue for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis as follows: 1064 nm wavelength * Tattoo Removal (dark ink: blue and black) » Dermal Pigmented Lesions; including, but not limited to: Nevus of Ota, Lentigines, Nevi, Melasma and Cafe-au-lait » Removal or lightening of hair with or without adjuvant preparation. » Skin Resurfacing for Acne Scars and Wrinkles * Benign cutaneous lesions; including, but not limited to: striac and Scars (excludes the 650nm wavelength) » Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength) 532 nm Wavelength » Tattoo removal (light ink: red, sky blue, green) * Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi * Epidermal Pigmented lesions; including, but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus, seborrheic keratosis » Skin Resurfacing for Acne Scars and Wrinkles * Benign cutaneous lesions; including, but not limited to: striae and scars, (excludes the 6SOnm wavelength) * Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

Source page: https://510kreport.com/device/K193266
Methodology: https://510kreport.com/methodology