(163 days)
No
The device description focuses on the hardware components and the mechanism of action (laser emission) and does not mention any software or algorithms that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is also explicitly marked as "Not Found".
Yes
The device is indicated for treatment of vascular lesions and benign pigmented lesions, which is a therapeutic use.
No
The device is indicated for permanent hair reduction, treatment of vascular lesions, and benign pigmented lesions, which are all therapeutic or cosmetic treatments, not diagnostic.
No
The device description clearly outlines physical hardware components including a laser medium, flash lamp, optical bench, cables, water lines, and a handpiece. It is a hardware module for an existing laser platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "permanent hair reduction," "treatment of vascular lesions," and "benign pigmented lesions." These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a laser module that emits light to interact directly with the patient's tissue. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a therapeutic and cosmetic laser system that interacts directly with the patient's skin.
N/A
Intended Use / Indications for Use
The Alma Lasers ALEX755 Module is indicated for permanent hair reduction, and the treatment of vascular lesions and benign pigmented lesions.
Product codes
GEX
Device Description
The Alma Lasers ALEX755 Module is an additional module to the existing Alma Lasers. Ltd. Harmony XLTM Multi-Application Platform (previously cleared under K072564).
The pistol-shaped Alex755 laser module incorporates a solid state Alexandrite rod laser medium and a xenon flash lamp as the heart of the optical bench. The flash lamp pumped Alexandrite rod emits light through an aperture located on the module tip. The laser beam is delivered when the operator presses both the footswitch, and the handpiece trieger,
The Alma Lasers ALEX755 Module is comprised of the following components;
- An 'umbilical' cable and connector, that is permanently attached to the ALEX755 module body and semi-permanently attached to the laser system
- Electrical cables (to provide power to the light source and to connect to a memory device that identifies the module)
- A supply and return water line (to remove the heat generated)
- Module body (shells) housing the module internals and connecting to the umbilical.
The operator holds the handpiece by its handle in order to position the module tip against the patient's skin. Optional air-cooling can be provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070805, K042474, K034030, K031488, K992757, K040055, K010715, K032991, K973354, K971874
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Section 5-510(k) Summary
I. General Information
AUG 1 3 2009
Submitter:
Alma Lasers, Ltd. c/o Alma Lasers, Inc. 485 Half Day Road Suite 100, Buffalo Grove, IL 60089
Contact Person:
Tatiana Epstein c/o Howard Kelly Regulatory Affairs Manager, Alma Lasers, Ltd. +011 972-4-627-5357
Summary Preparation Date:
July 13, 2009
II. Names
Device Names:
Alma Lasers ALEX755 Module
Primary Classification Names: Laser Instrument, Surgical, Powered
Predicate Devices III.
- · K070805 Ultrawave II EX 1320 Quanta System SpA
- · K042474 ARION WaveLight Laser Technologie, AG
- · K034030 Cynosure Apogee Elite Laser Cynosure, Inc.
- · K031488 Cynosure Apogee-TKS II Laser Cynosure, Inc.
- · K992757 Cynosure Apogee Laser Cynosure, Inc.
- · K040055 Polylase LP DDC Technologies, Inc.
- · K010715 AL40 DDC Technologies, Inc.
- · K032991 Light Age EpiCare Aexandrite Laser Light Age, Inc.
- · K973354 Sharplan EpiTouch Model 5000 Alexandrite Laser System Sharplan Lasers, Inc.
· K971874 - Sharplan EpiTouch Model 5000 Alexandrite Laser System - Sharplan Lasers, Inc.
IV. Product Description
The Alma Lasers ALEX755 Module is an additional module to the existing Alma Lasers. Ltd. Harmony XLTM Multi-Application Platform (previously cleared under K072564).
The pistol-shaped Alex755 laser module incorporates a solid state Alexandrite rod laser medium and a xenon flash lamp as the heart of the optical bench. The flash lamp pumped Alexandrite rod emits light through an aperture located on the module tip. The laser beam is delivered when the operator presses both the footswitch, and the handpiece trieger,
The Alma Lasers ALEX755 Module is comprised of the following components;
018
1
- An 'umbilical' cable and connector, that is permanently attached to the v ALEX755 module body and semi-permanently attached to the laser system
-
Electrical cables (to provide power to the light source and to connect to a memory device that identifies the module)
- A supply and return water line (to remove the heat generated)
- Module body (shells) housing the module internals and connecting to the > umbilical.
The operator holds the handpiece by its handle in order to position the module tip against the patient's skin. Optional air-cooling can be provided.
V. Indications for Use
The Alma Lasers ALEX755 Module is indicated for permanent hair reduction, and the treatment of vascular lesions and benign pigmented lesions.
VI. Rationale for Substantial Equivalence
The Alma Lasers ALEX755 Module shares the same indications for use, the operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers ALEX755 Module is substantially equivalent to the predicate devices.
VIII. Conclusion
The Alma Lasers ALEX755 Module was found to be substantially equivalent to the predicate devices.
The Alma Lasers ALEX755 Module shares the same or similar indications for use, similar design and functional features with, and thus is substantially equivalent to the predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wavy lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Alma Lasers, Ltd. % Alma Lasers, Inc. Ms. Anne Worden Regulatory Consultant 485 Half Day Road, Suite 100 Buffalo Grove, Illinois 60089
AUG 1 3 2009
Re: K090571
Trade/Device Name: Alma Lasers ALEX755 Module Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 13, 2009 Received: July 15, 2009
Dear Ms. Worden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls: Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Ms. Anne Worden
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark M. Milhem
Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known): | K090571 |
|---|---|
| Device Name: | Alma Lasers ALEX755 Module |
Indications for Use:
The Alma Lasers ALEX755 Module to be used with the Harmony XL™ Multi-Application Platform is indicated for permanent hair reduction. Also indicated for the treatment of vascular lesions and benign pigmented lesions.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mich. B.P. Ols. for mkm
sion Sign Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090571
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