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Lelo Tor 2 Black 1812

by Leloi AB

Lelo Tor 2 Black 1812 is a Class II device made by Leloi AB, listed in FDA GUDID since 21 Sep 2016 (UDI-DI 07350022271821), registry data as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07350022271821 UDI-DI Date21 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  • Withdrawn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
Lelo Tor 2 Black
Generic name
Penile ring
Model / reference
1812
Primary DI / UDI-DI
07350022271821
FDA product code
LKY
GMDN term
Penile ring
Device class
Class II
Regulation number
876.5020
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code LKY (Device, External Penile Rigidity).

Other devices from Leloi AB

See all devices from Leloi AB →

Properties

  • Over-the-counter
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)