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Lumenis Ltd

Active in EUDAMED

Israelfrom SRN EUDAMED SRN IL-MF-000016033

Devices
20
Registrations
EUDAMED
FDA recalls
72 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
United States
FDA recalls

Catalogue20

Newest first, rows 1-20 of 20

Search and filter all 20 devices
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  • Pulse™ Ref M0068S23477JP

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C06900

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068S06801

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068S23476JP

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068S29996

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C08700

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C23476JP

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068S06900

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068S06900CN

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C29996

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C06801

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068S08700

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068S08800

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C08800

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C06902

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068S06802

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C06900CN

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C23477JP

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068S06902

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

  • Pulse™ Ref M0068C06802

    Active Regimes: CE MDR Registry: EUDAMED Class:IIb

Rows 1-20 of 20

Company details

EUDAMED SRN
IL-MF-000016033
DUNS number
600166524
EUDAMED status
Active since 2023
EUDAMED registered name
LUMENIS LTD
Registered address
6, Hakidma, 2069204, Yokneam, Israel
Phone
408-764-3000
PRRC contact
Rachel Dvir(public in EUDAMED)

FDA recalls7

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 2
  • 2026 0

5 initiated before 2017

  • 2025

    • 22 Jul 2025 Z-2344-2025 Class II Ongoing The potential for unsterilized product within finished product labeled as sterile. Distribution: Domestic: PA, WI; International: Germany, India; Submission number: K130164
    • 23 Jan 2025 Z-1290-2025 Class II Ongoing The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on. Distribution: Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and…
      Full distribution text Distribution was made to PA. There was no government/military distribution. Foreign distribution was made to Mexico and Spain.
      Submission number: K170121

  • 2016

    • 25 Sep 2016 Z-0301-2017 Class II Terminated The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination. Distribution: Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India,…
      Full distribution text Worldwide Distribution -- USA, Italy, Russian Fed., Australia, United Arab Emirates, Spain, United Kingdom, India, Kuwait, and Belarus.
      Submission number: K100415

  • 2015

    • 17 Nov 2015 Z-1669-2016 Class II Terminated Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device. Distribution: Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany,…
      Full distribution text Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.
      Submission number: K142860
    • 30 Jul 2015 Z-2770-2015 Class II Terminated There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue. Distribution: Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China,…
      Full distribution text Worldwide Distribution - US including CA, PA, MA, FL, and NY, and Internationally to Italy, Germany, Australia, China, Great Britian, United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.
      Submission number: K133272
    • 25 Mar 2015 Z-1519-2015 Class II Terminated Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation. Distribution: Worldwide distribution. US nationwide (to OR, NM, NY, IL, and CO), Switzerland, Canada, Italy, Great Britain, United…
      Full distribution text Worldwide distribution. US nationwide (to OR, NM, NY, IL, and CO), Switzerland, Canada, Italy, Great Britain, United Arab Emirates, France, Belgium, India, Israel, Japan, Portugal, Czech Republic, Kuwait, Germany, Spain, Georgia, Armenia, Slovenia, New Zealand, Saudi Arabia, and Russian Federation.
      Submission number: K003614

  • 2013

    • 2 Jan 2013 Z-0795-2013 Class I Terminated Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up. Distribution: Worldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ,…
      Full distribution text Worldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ, NH, MN, TN, OK, KY, TX, AK, MI, VT. Internationally: Japan, Nepal, India, UK, South Korea, Netherlands, Germany, Australia, China, Canada, Turkey, Spain, Italy, Egypt, Mexico, Bulgaria, Utd. Arab, Emir., Poland, Kuwait, Hong Kong, Saudi Arabia, Yemen, Qatar, Czech Republic, New Zealand, Malaysia, Portugal, France, Argentina, Singapore, Romania, Chile, Colombia, Switzerland, Bahrain, Brazil, Serbia/Montenero, Taiwan, Israel, Indonesia, Peru, Pakistan, Nepal, Belarus, Latvia, Sri Lanka, Russian Fed, Thailand, Azerbaijan, Belgium, and Denmark.
      Submission number: K050639

Frequently asked questions

How many devices does LUMENIS LTD have in the registry?

The registry currently lists 20 devices for LUMENIS LTD. Devices recorded under merged duplicate company entries are counted once.

Which registries list LUMENIS LTD's devices?

Among its 20 most recently registered devices, LUMENIS LTD has devices listed in EUDAMED (20 devices).

What risk classes do LUMENIS LTD's devices fall under?

Among its 20 most recently registered devices, the classes recorded for LUMENIS LTD's devices are Class IIb. Each device page shows its own class and authorisation.

Are there FDA recall records for LUMENIS LTD?

FDA recall records list 7 recalls initiated by LUMENIS LTD, the most recent initiated on 22 Jul 2025. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from LUMENIS LTD in the registry?

The most recently registered devices listed for LUMENIS LTD include Pulse™.

Generated automatically from registry data and not verified by a human reviewer.