MIIN

Medico USA, Inc.

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

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

4

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K193266
Device name
MIIN
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-11-26
Decision date
2021-01-22
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentVascular treatmentSurgical cutting
Primary application
Pigment treatment
Classification source
AI classified

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: striae 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 650nm wavelength)
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)

Intended 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 650nm wavelength), Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength).

Device Description

MIIN applies the Nd:YAG laser source and it is composed of main body part, hand piece part and arm part mainly. The main body part is consisted of laser module from which beam is irradiated, power module, control module and touch screen. MIIN, The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064nm) and frequency Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. The MIIN Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermal therapy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body. The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.

Summary parsed at:2026-06-01 05:41:14 UTC

Predicate devices

4

K193266 references 4 predicate/reference devices

Cited as predicate

1

1 submission cite K193266 as a predicate