Bare: 808— 510(k) K193446
Substantially EquivalentLuvo Medical Technologies, Inc.
FDA 510(k) clearance K193446 for Bare: 808, Substantially Equivalent on 2020-03-10. Applicant: Luvo Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Luvo Medical Technologies, Inc.
- Product code
- 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
- Cambridge, CA
Recent devices under product code GEX
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- K262070 — Diode Laser Therapy Systems (DL612A)
- K261841 — Q Switched Nd:YAG Laser machine (QLQW-01)
- K261221 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
More clearances from Luvo Medical Technologies, Inc.
view allAdverse 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.