LUNE PureHygiene— 510(k) K260138
Substantially EquivalentEnamel Pure
FDA 510(k) clearance K260138 for LUNE PureHygiene, Substantially Equivalent on 2026-05-29. Applicant: Enamel Pure. Device class: 2.
Summary
Enamel Pure's LUNE PureHygiene is filed under GEX, powered laser surgical instruments. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 878.4810. The Dental review panel handled it as a Traditional 510(k), though the record lists General and Plastic Surgery as the classification panel.
Enamel Pure filed from Worcester, Massachusetts. Review took 133 calendar days (January 16 to May 29, 2026).
Clearance details
- Applicant
- Enamel Pure
- 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
- Worcester, MA, US
Recent devices under product code GEX
view allMore 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.