IRIS Pi Q switched Nd YAG laser

Bio-Med 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

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1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K221789
Device name
IRIS Pi Q switched Nd YAG laser
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2022-06-21
Decision date
2022-08-09
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Surgical cuttingPigment treatmentVascular treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

IRIS Pi Q switched Nd YAG laser system is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgery procedures for coagulation and hemostasis. 532nm wavelength Tattoo removal light ink (red, tan, purple, orange, sky blue) Removal of benign epidermal pigmented lesions, Minor benign vascular lesions, Telangiectasias Treatment of Lentigines, Cafe-Au-Lait, Seborrheic Keratoses, Becker's Nevi, Freckles. Treatment of Post inflammatory Hyperpigmentation (PIH) 1064nm wavelength Tattoo removal dark ink (black, blue, green) Removal of Nevus of Ota, Removal or lightening of unwanted hair, Treatment of Common Nevi, Melasma Skin resurfacing procedures for treatment of Acne Scars, Wrinkle.

Intended Use

IRIS Pi Q switched Nd YAG laser system is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgery procedures for coagulation and hemostasis. 532nm wavelength Tattoo removal light ink (red, tan, purple, orange, sky blue) Removal of benign epidermal pigmented lesions, Minor benign vascular lesions, Talangiectasias Treatment of Lentigines, Cafe-Au-Lait, Seborrheic Keratoses, Becker's Nevi, Freckles. Treatment of Post inflammatory Hyperpigmentation (PIH) 1064nm wavelength Tattoo removal dark ink (black, blue, green) Removal of Nevus of Ota, Removal or lightening of unwanted hair, Treatment of Common Nevi, Melasma Skin resurfacing procedures for treatment of Acne Scars, Wrinkle.

Device Description

The IRIS Pi Q-Switched Nd:YAG laser system produces a two pulsed beam, 1064 nm Infrared and 532nm long pulse laser, and using two non-fractional handpieces (Zoom handpiece and 7mm collimated handpiece) is able to control various treatment fluence. The laser tube is placed in the mixed crystals of copper pipe to the heater and produces a laser beam. The resonator amplifies the beam through the Xe-gas contained lamp, which is a high pressure lamp to increase specific laser beam. This converted light energy creates the Nd:YAG crystal and exhaust from the crystal is amplified into a specific wavelength. Laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed adjustable spot size handpiece. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using a foot switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit. This system also consists of an optic main bench assembly, articulated arm handpieces, LCD control panel, cooling system, and foot pedal switch.

Summary parsed at:2026-06-01 05:40:11 UTC

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