(89 days)
Quantum SR
No
The document does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on light-based treatment and comparisons to predicate devices based on specifications and performance studies without mentioning AI/ML.
Yes.
The device is intended for "photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions," which describes therapeutic applications.
No.
The device is used for photocoagulation and photothermolysis, which are treatment procedures rather than diagnostic ones.
No
The device description explicitly states it is a "handpiece," which is a hardware component, and an "accessory to the EsteLux Pulsed Light System," which is also a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for photocoagulation and photothermolysis of dermatological vascular lesions and treatment of benign pigmented lesions. These are procedures performed directly on the patient's body using light energy.
- Device Description: The device is described as a handpiece accessory to a pulsed light system, designed for treating veins and pigmented lesions. This further reinforces its use as a therapeutic device applied externally to the patient.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of biological specimens.
Therefore, the LuxGTM handpiece is a therapeutic medical device used for external treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EsteLux™ System is intended for effective treatment of facial and leg veins, and treatment of pigmented lesions in all skin types (I-VI).
The LuxGTM handpiece is intended for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
Product codes
GEX
Device Description
The LuxGTM handpiece is an accessory to the EsteLux Pulsed Light System, a light-based medical device designed for effective treatment of facial and leg veins, and treatment of pigmented lesions in all skin types (I-VI).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial and leg veins, dermatological vascular lesions, benign pigmented lesions
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)
The differences in the specifications of the EsteLux LuxG™, the EsteLux Standard handpiece and the Quantum SR do not result in different performance or raise new questions of safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
EsteLux Standard handpiece, Lumenis (ESC) Quantum SR
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.
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Attachment 5
K b2094J
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the LuxG™ handpiece is submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Palomar Medical Technologies, Inc. |
|---|---|
| Address: | 82 Cambridge St. |
| Burlington, MA 01803 | |
| 781-993-2300 | |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | February 6, 2002 |
| Device Trade Name: | Palomar LuxGTM |
| Common Name: | LuxGTM |
| Classification Name: | Laser surgical instrument for use in General and |
| Plastic Surgery and in Dermatology | |
| (see: 21 CFR 878-4810). | |
| Product Code: GEX | |
| Panel: 79 | |
| Legally-Marketed Predicate Device: | EsteLux Standard handpiece |
| Lumenis (ESC) Quantum SR | |
| System Description: | The LuxGTM handpiece is an accessory to the |
| EsteLux Pulsed Light System, a light-based medical | |
| device designed for effective treatment of facial and | |
| leg veins, and treatment of pigmented lesions in all | |
| skin types (I-VI). | |
| Intended Use of the Device: | The EsteLux™ System is intended for effective |
| treatment of facial and leg veins, and treatment of | |
| pigmented lesions in all skin types (I-VI). |
CONFIDENTIAL AND PROPRIETARY
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Performance Data:
The differences in the specifications of the EsteLux LuxG™, the EsteLux Standard handpiece and the Quantum SR do not result in different performance or raise new questions of safety or efficacy.
Conclusion:
Based on the foregoing, the LuxGTM handpiece is substantially equivalent to the legally-marketed claimed predicate devices.
CONFIDENTIAL AND PROPRIETARY
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Marcy Moore Manager of Clinical Studies Palomar Medical Technologies, Inc. 131 Kelekent Lane Cary, NC 27511
JUN 1 9 2002
Re: K020941 Trade/Device Name: LuxGTM Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 21, 2002 Received: March 22, 2002
Dear Ms. Moore:
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 - Ms. Marcy Moore
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Stupt Rhodes
Celia 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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Corrected Pages
INDICATIONS FOR USE STATEMENT
K 020941 510(K) Number:
LuxGTM Device Name:
Indications for Use:
The LuxGTM handpiece is intended for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-the-Counter Use (per-21 CFR 801.109)
Sturt Rhodes
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KOZO941 510(k) Number _
CONFIDENTIAL AND PROPRIETARY
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