Picore

Bio-Med USA, Inc.

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

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K212082
Device name
Picore
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

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