LUNE PureHygiene— 510(k) K234085
Substantially EquivalentEnamel Pure
FDA 510(k) clearance K234085 for LUNE PureHygiene, Substantially Equivalent on 2024-03-25. Applicant: Enamel Pure. Device class: 2.
Clearance details
- Applicant
- Enamel Pure
- 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
- Worcester, MA, US
Recent devices under product code GEX
view all- K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
- K261964 — ECHOLASER X4
- 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 Enamel Pure
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.