(76 days)
No
The document describes a laser device for tattoo and lesion removal and does not mention any AI or ML components or functionalities.
Yes
The device is used for medical treatments like the removal of dark tattoos and the treatment of pigmented lesions, which are therapeutic applications.
No
The device's intended use is for treatment (removal of dark tattoos, treatment of pigmented lesions) through selective photothermolysis and photo-acoustic effects, not for diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a system console, control and display panel, and delivery handpiece(s) (Treatment Heads), in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a laser treatment head used for procedures performed directly on the patient's skin (removal of tattoos and treatment of pigmented lesions). It operates through selective photothermolysis and photo-acoustic effects on target chromophores within the tissue.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its function is to deliver laser energy to the patient's body.
Therefore, this device falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores.
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for:
- Removal of dark tattoos
- Treatment of pigmented lesions
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components:
- A system console (including software and control electronics, key-operated power control switch, power-on indicator, emergency shut-off knob and a remote interlock connector);
- . A control and display panel;
- One or more delivery handpiece(s), the Treatment Heads.
The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system.
The Q-switched Nd: YAG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.
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
medical specialties of plastic surgery and dermatology
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)
A Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K011677, K033259, K003460, K023967
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K020839, K030527, K024093, K030342
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Attachment 17 K043173 510(k) Summary for the Q-switched Nd: YAG Laser Treatment Head for the Lumenis Quantum Series
I. General Information
| Submitter: | Lumenis, Inc.
2400 Condensa Street
Santa Clara, CA 95051 |
|---------------------------|----------------------------------------------------------------|
| Contact Person: | Martha Murari, Ph.D.
Senior Regulatory Affairs Associate |
| | Connie Hoy
Global Director RA / QA |
| Summary Preparation Date: | November 15, 2004 |
II. Names
Device Names:
Q-switched Nd:YAG Laser Treatment Head for the Quantum Series
Laser Powered Surgical Instrument (and Accessories) Primary Classification Name:
Predicate Devices III.
- Lumenis family of Intense Pulsed Light (IPL) and IPL/Nd: YAG laser systems (K020839, . K030527, K024093, K030342) marketed by Lumenis.
- MedLite C3- Q Switched Nd: YAG laser (K011677) marketed by Hoya ConBio (formerly ● Continuum Electro-Optics)
- Light-Age O-Clear laser (K033259) marketed by Light Age Inc. .
- Q-YAG 5 laser (formerly Clear Light)(K003460, K023967) marketed by Palomar ● Medical Technologies Inc.
IV. Product Description
The Lumenis Quantum series of IPL/Nd: YAG systems are intense pulsed-light (IPL) and Nd: Y AG laser devices. Each Quantum system is comprised of three main components:
- A system console (including software and control electronics, key-operated power control . switch, power-on indicator, emergency shut-off knob and a remote interlock connector);
- . A control and display panel;
- One or more delivery handpiece(s), the Treatment Heads. .
The Q-switched Nd: Y AG Treatment Head for the Quantum series is a pulsed laser operating at a wavelength of 1064 nanometers. It is an upgrade that can be installed on any Quantum system.
The Q-switched Nd: Y AG Laser Treatment Head is a hand held device comprised of the laser head and optics, trigger circuit, safety components and cooling circuit. The Qswitched Nd: YAG Laser Treatment Head is connected to the Quantum console via an umbilical cable and connector.
510(k) Submission: Q-switched Nd: YAG Laser Treatment Head for the Quantum Series Attachment 17 - Page 1
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V. Indications for Use
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is intended for use in the medical specialties of plastic surgery and dermatology for applications requiring selective photothermolysis and photo-acoustic effects in target chromophores.
The Q-switched Nd: YAG Laser Treatment Head for the Quantum series is indicated for:
- Removal of dark tattoos �
- Treatment of pigmented lesions .
Rationale for Substantial Equivalence VI.
The Q-switched Nd:YAG Laser Treatment Head for the Quantum series shares the same indications for use as the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460), in that the 1064 nm wavelength is indicated for:
- Removal of dark tattoos �
- Treatment of pigmented lesions .
The technical specifications of the Q-switched Nd: YAG Laser Treatment Head for the Quantum series are similar or identical to those of the predicate MedLite C3 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460).
Therefore, the Q-switched Nd:YAG Laser Treatment Head for the Quantum series is substantially equivalent to the predicate devices.
Safety and Effectiveness Information VII.
The Q-switched Nd:YAG Laser Treatment Head for the Quantum series shares the same indications for use, same principle of operation, same wavelength, same or similar fluence range and spot sizes as the predicate devices. A Clinical Evaluation Report demonstrated the safety and effectiveness of the Q-switched Nd: YAG laser for the claimed indications for use. The Q-switched Nd: Y AG Laser Treatment Head for the Quantum series does not raise new questions of safety and efficacy.
VIII. Conclusion
Based on the foregoing, the Q-switched Nd: Y AG Laser Treatment Head for the Quantum series was found to be substantially equivalent to the predicate MedLite C2 Q-switched Nd: YAG laser system (K011677), the Q-Clear laser system (K033259) and the Q-YAG 5 / Clear Light (K003460).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle-like symbol with three curved lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 1 2005
Lumenis, Ltd. c/o Martha Murari, Ph.D. Senior Regulatory Affairs Associate Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051
Re: K043173
Trade/Device Name: Q-switched Nd:YAG Laser Treatment Head for the Lumenis Quantum series (Quantum HR, Quantum SR and Quantum DL) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 15, 2004 Received: November 16, 2004
Dear Dr. Murari:
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 such 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 CFR Part 807); labeling (21 CFR Part 801); 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.
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Page 2 – Martha Murari, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organ maing of substantial equivalence of your device to a legally premative hotification. The PDF Interessification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advision at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour Copsumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Miriam C. Provost
Cclia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):