# K171648: BM.Iris

- Pathway: 510(k) (Traditional)
- Applicant: Bluecore Co., Ltd.
- Decided: Sep 8, 2017 after 95 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K910422 (1992). 129 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113588: Spectra Laser System, Lutronic Corporation (2012) Summary page 4.

## Most influential descendants
- K221789: IRIS Pi Q switched Nd YAG laser (2022), 0 descendants of its own
- K212082: Picore (2021), 0 descendants of its own

## Indications for use
IRIS 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, Sebrorrheic 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

Source page: https://510kreport.com/device/K171648
Methodology: https://510kreport.com/methodology