ALMA LASERS LTD.

FDA Device Registration & Listing · CAESAREA Northern, IL · Registration 3004167969

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004167969
FEI Number
3004167969
Entity Name
ALMA LASERS LTD.
City/State/Country
CAESAREA Northern, IL
Establishment Address
18 Haharash Street, NORTH INDUSTRIAL PARK, CAESAREA Northern 3079895, IL
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ALMA LASERS LTD. (Owner Number: 9055441)
Owner / Operator Contact Address
485 half day rd, Buffalo Grove, IL 60089, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K233024
PMA Number
N/A

All Registered Proprietary Names

The Alma Soprano Titanium Soprano ICE Platinum HarmonyXL MultiApplication Platform; Harmony XL Pro; Beauty Rejuve LMNT One Alma Harmony Alma Q Alma LipoFlow System Arion Modified Family of Lovely Systems; LOVELY II (HARMONY); LOVEY I (ARIA); Harmony Elite Pixel RF Tips; Opus System; Beauty Reform 308 Dermatological Excimer System Lipolife Family; Alma LipoFlow System vShape Ultra; Accent Prime Alma Diode Tabletop Laser Alma Veil Alma Hybrid Laser System Sinon The Alma Opus System, Colibri Applicator and Tips Alma DUO The Alma Soprano Titanium Liposense/BeautiFirm Accent UniForm Massager Module Soprano XL Multi-Application Platform; Beauty Remove Alma Family of Thermo XEL Handpieces LOVELY II (HARMONY); Lovely System Models; LOVELY I (ARIA) EXELO2, MODEL 4010 Beauty Reform; Accent Elite Harmony XL Multi-Application Platform FemiLift / Pixel CO2 Laser System Alma Pixel Modified Harmony 1064nm Nd:YAG Modules Alma Veil The Alma Hybrid Laser System Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece VorFat System / Cellfie Mydon C LMNT 02 Alex 755 Harmony XL Module Alma TED Family of Multi-application systems Soprano XL/XLi Idas Alma Harmony

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUG Medical Device Data System General Hospital Class 1 880.6310 2023-05-05
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2023-05-05
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-05-05
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2018-09-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-09-10
FTC Light, Ultraviolet, Dermatological General, Plastic Surgery Class 2 878.4630 2008-10-16
HHR Laser, Surgical, Gynecologic Obstetrics/Gynecology Class 2 884.4550 2008-10-16
LNK Laser For Gastro-Urology Use General, Plastic Surgery Class 2 878.4810 2008-10-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-10-16
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2022-04-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-12-01
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2017-06-22
QKL Lipoaspirate Washing System For Aesthetic Body Contouring General, Plastic Surgery Class 2 878.5040 2023-04-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-11-09
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2003-09-29
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-14
FTC Light, Ultraviolet, Dermatological General, Plastic Surgery Class 2 878.4630 2016-11-09
MUU System, Suction, Lipoplasty General, Plastic Surgery Class 2 878.5040 2017-07-18
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2016-09-19
NUV Massager, Vacuum, Light Induced Heating General, Plastic Surgery Class 2 878.4810 2016-09-19
IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat Physical Medicine Class 2 890.5300 2016-09-19
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2016-09-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-08-17
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-07-07
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-06-04
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-11-09
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2021-11-09
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2024-07-18
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2022-11-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-11-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-11-02
NUV Massager, Vacuum, Light Induced Heating General, Plastic Surgery Class 2 878.4810 2009-11-15
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2009-11-15
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2009-11-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2009-11-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2008-10-16
FTC Light, Ultraviolet, Dermatological General, Plastic Surgery Class 2 878.4630 2003-09-29
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2003-09-29
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2016-11-09
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2011-11-14
NUV Massager, Vacuum, Light Induced Heating General, Plastic Surgery Class 2 878.4810 2011-11-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2011-11-14
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2018-09-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2011-03-27
PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis General, Plastic Surgery Class 2 878.4810 2012-11-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2012-11-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2023-09-29
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-07-04
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2017-06-12
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2017-06-12
QKL Lipoaspirate Washing System For Aesthetic Body Contouring General, Plastic Surgery Class 2 878.5040 2023-06-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-11-09
OHS Light Based Over The Counter Wrinkle Reduction General, Plastic Surgery Class 2 878.4810 2026-05-29
OLP Over-The-Counter Powered Light Based Laser For Acne General, Plastic Surgery Class 2 878.4810 2026-05-29
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2009-11-15
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2023-05-04
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2010-12-01
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2016-11-09
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2024-02-29
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-02-29
ILY Lamp, Infrared, Therapeutic Heating Physical Medicine Class 2 890.5500 2024-02-29

Official Correspondent

Avi Farbstein

US Agent Details

Avi Farbstein Email: Regulatory@almalasers.com Phone: (224) 3772011

Related Public Records

Same Entity

ALMA LASERS LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

Registration Number Establishment Name Location
3026606276 KEY ASIC BERHAD PETALING JAYA Selangor, MY
3043603319 MEDICARE TAGS LIMITED T/A MEDYTRAK Galway, IE
3002725312 AMERICAN PORTWELL TECHNOLOGY, INC. Fremont, CA, US
3007832484 JWP MANUFACTURING Santa Clara, CA, US
3037966017 HEALTH DATA WORKS Ponte Vedra Beach, FL, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004167969. Last updated year: 2026. Please use registration number 3004167969 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.