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Sirona Sirona 100

by Wuhan Dimed Laser Technology Co., Ltd.

Sirona Sirona 100 is a Class II device made by Wuhan Dimed Laser Technology Co., Ltd., listed in FDA GUDID since 16 Oct 2025 (UDI-DI 06974214160802), 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 Number06974214160802 UDI-DI Date16 Oct 2025ListedStatusListed 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  • Withdrawn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
Sirona
Generic name
General/multiple surgical diode laser system
Model / reference
SIRONA 100
Primary DI / UDI-DI
06974214160802
FDA product code
PDZ, ILY
GMDN term
General/multiple surgical diode laser system
Device class
Class II
Regulation number
878.4810, 890.5500
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Similar devices

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

Other devices from Wuhan Dimed Laser Technology Co., Ltd.

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Properties

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