# K211335: Diode Laser Machine, Model Number: BM-100

- Pathway: 510(k) (Traditional)
- Applicant: Zhengzhou Bestview ST Co., Ltd.
- Decided: Jul 28, 2021 after 86 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: 14 generations back to K910422 (1992). 62 ancestors in all.
5 later devices descend from it; 5 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162659: Diode Laser Hair Removal System, Shandong Huamei Technology Co., Ltd. (2017) Summary page 5.

## Most influential descendants
- K262070: Diode Laser Therapy Systems (DL612A) (2026), 0 descendants of its own
- K252427: Diode Laser Hair Removal Machine (GLD01) (2025), 0 descendants of its own
- K241547: Diode Laser Therapy Device (DF-DIODE LASER-S1) (2024), 0 descendants of its own
- K241642: Diode Laser Hair Removal System (MBT-Diode Laser) (2024), 0 descendants of its own
- K223778: Diode Laser Hair Removal System (RD-SLD600) (2023), 0 descendants of its own

## Indications for use
The Diode Laser Machine (Model: BM-100) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6,9, and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K211335
Methodology: https://510kreport.com/methodology