# K230268: ZenPro 40

- Pathway: 510(k) (Traditional)
- Applicant: BLUECORE COMPANY Co., Ltd.
- Decided: Aug 10, 2023 after 191 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Non-fractional mode is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynecology, neurosurgery, dental and oral surgery and genitourinary surgery. Fractional mode is indicated for only ablative skin resurfacing

Source page: https://510kreport.com/device/K230268
Methodology: https://510kreport.com/methodology