Manufacturer
Bio-Med USA, Inc.IRIS Pi Q switched Nd YAG laser
Country / Region:United States (US)Submission type:Traditional
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
- K221789
- Device name
- IRIS Pi Q switched Nd YAG laser
- Company
- Bio-Med USA, Inc.
- 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
Predicate devices
1BM.IRIS
K221789 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K221789 as a predicate
