Manufacturer
Bio-Med USA, Inc.Picore
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
- K212082
- Device name
- Picore
- 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
- 2021-07-02
- Decision date
- 2021-10-06
- Submission type
- Special
- Technology type
- Q-Switched(AI inferred)
- Clinical applications
- Pigment treatmentVascular treatmentSurgical cutting
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
PICORE Q-switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical 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 with or without adjuvant preparation, Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkle.
Intended Use
PICORE Q-switched Nd:YAG Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical 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 with or without adjuvant preparation, Treatment of Common Nevi, Melasma, Skin resurfacing procedures for the treatment of acne scars, wrinkles.
Device Description
The subject device PICORE is a picosecond Nd:YAG laser instrument that uses Nd:YAG as a medium to emit a laser beam of 1064nm and 532nm wavelength. It has four non-fractional handpieces (Zoom handpiece, 7mm collimated handpiece, 3-5 mm handpiece, 6-8 mm handpiece). A physician can optimize the treatment effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam. Laser emission can be controlled by 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.
Summary parsed at:2026-06-01 05:43:29 UTC
Predicate devices
1BM.IRIS
K212082 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 K212082 as a predicate
