Skip to content

Lunula FFS

by Erchonia Corporation

Lunula FFS is a Class II device made by Erchonia Corporation, listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00858985006056), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858985006056 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Lunula
Generic name
Nail laser phototherapy unit
Model / Ref / Catalog
FFS
Primary DI / UDI-DI
00858985006056
FDA product code
PDZ
GMDN term
Nail laser phototherapy unit
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nail laser phototherapy unit

Similar devices

Other devices filed under FDA product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis).

Other devices from Erchonia Corporation

  • Evrl-Otc EVRL3-Otc

    Class II

  • Erchonia CLX CFL

    Class II

  • Zerona 2.0 GLS

    Class II

  • FX635 Hps

    Class II

See all devices from Erchonia Corporation →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)