B`orze Inc Laser Family (Sorren/Adonis)— 510(k) K263063
Substantially EquivalentBorze, Inc.
FDA 510(k) clearance K263063 for B`orze Inc Laser Family (Sorren/Adonis), Substantially Equivalent on 2026-10-30. Applicant: Borze, Inc.. Device class: 2.
Clearance details
- Applicant
- Borze, Inc.
- Product code
- Product code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boise, ID, US
Recent devices under product code GEX
view all- K262349 — Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)
- K262627 — Fractional CO2 Laser Therapy System (Z121)
- K262701 — PicoPeak Picosecond Nd:Yag Laser System (Bella-9)
- K262628 — Picosecond Laser treatment system (Z180)
- K261572 — Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.