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Ellipse Nordlys

by Ellipse A/S 2 variants

Ellipse Nordlys (9SYS7751) is a Class II device made by Ellipse A/S, cleared under FDA 510(k) K161162 on 16 Sep 2016 (1 earlier submission) and listed in FDA GUDID since 5 Aug 2019 (UDI-DI 05713530000420), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05713530000420 UDI-DI Date5 Aug 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161162 Date16 Sep 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161162 decided 16 Sep 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05713530000420 listed 5 Aug 2019 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K150907
  2. Cleared FDA 510(k) K161162
  3. Listed FDA GUDID 05713530000420

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ellipse
Generic name
Multi-modality skin surface treatment system
Model / Ref / Catalog
Nordlys, 9SYS7751
Primary DI / UDI-DI
05713530000420
510(k) Number
FDA product code
GEX
GMDN term
Multi-modality skin surface treatment system
Device class
Class II
Regulation number
878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality skin surface treatment system

Cleared under the same submission (K150907)

and 8 more cleared under K150907

Cleared under the same submission (K161162)

Similar devices in this category

Other devices filed under Multi-modality skin surface treatment system.

Other devices from Ellipse A/S

See all devices from Ellipse A/S →

Properties

  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)