(45 days)
Not Found
No
The summary describes a laser handpiece and system with standard controls and cooling, with no mention of AI, ML, image processing, or data-driven decision-making.
Yes
The device is used for "Dermatological procedures requiring the coagulation of soft tissue," and the performance data mentions "fractional photothermolysis," indicating its use in treating the skin. These are therapeutic applications.
No
The device is described as performing dermatological procedures requiring the coagulation of soft tissue, specifically fractional photothermolysis, which is a therapeutic rather than a diagnostic function. There is no mention of it being used to identify or analyze medical conditions.
No
The device description clearly outlines hardware components including a handpiece, power source, chiller, footswitch, and umbilical, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Dermatological procedures requiring the coagulation of soft tissue." This describes a therapeutic or surgical procedure performed directly on the patient's body.
- Device Description: The description details a laser handpiece used in contact with the skin to deliver light for tissue coagulation. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
Dermatological procedures requiring the coagulation of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Palomar Lux1540 Handpiece delivers light with a wavelength of 1540 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical. In standard use, the handpiece is held in firm contact with the skin. The handpiece tip is water-cooled to offer active skin System parameters and other system cooling. features are controlled from the user interface panel on top of the power unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Performance data was provided showing the Lux1540 is capable of performing fractional photothermolysis, i.e., creation of a pattern (lattice) of microscopic islets of damage at superficial skin layers.
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.
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.
Not Found
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 4
510(K) Summary of Safety and Effectiveness
This 510(K) Summary of Safety and Effectiveness for the Palomar Lux1540 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 | |
| Contact Person: | Marcy Moore |
| Telephone: | 919-363-2432 |
| Preparation Date: | February 2, 2006 |
| Device Trade Name: | Palomar Lux1540 Handpiece |
| Common Name: | Lux1540 |
| Classification Name: | Laser surgical instrument for use in General and |
| Plastic Surgery and Dermatology (21 CFR | |
| 878.4810) | |
| Product Code: | GEX |
| Legally-Marketed Predicate Device: | Reliant Fraxel |
System Description:
The Palomar Lux1540 Handpiece delivers light with a wavelength of 1540 nm. The complete system consists of a power source, chiller, a footswitch, and a handpiece connected to the power unit with an umbilical. In standard use, the handpiece is held in firm contact with the skin. The handpiece tip is water-cooled to offer active skin System parameters and other system cooling. features are controlled from the user interface panel on top of the power unit.
1
Intended Use of the Device: Dermatological requiring the Performance Data: Performance data was provided showing the Lux1540 is capable of performing fractional photothermolysis, i.e., creation of a pattern (lattice) of microscopic islets of damage at superficial skin layers. Conclusion: Based on the foregoing, the Palomar Lux1540 Handpiece is substantially equivalent to the legallymarketed claimed predicate device, namely the Reliant Laser System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2006
Palomar Medical Technologies, Inc. c/o Ms. Marcy Moore Manager of Clinical Studies 131 Kelekent Lane Cary, North Carolina 27511
Re: K060301
Trade/Device Name: Palomar Lux1540 Handpiece 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: February 2, 2006 Received: February 6, 2006
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
3
Page 2 - Ms. Marcy Moore
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. 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), please contact the Office of Compliance at (240) 276-0120. 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 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 yours,
Helmut Lemke
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KOGO301 510(k) Number (if known):
Palomar Lux1540 Handpiece Device Name:
Indications for Use:
Dermatological procedures requiring the coagulation of soft tissue.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Concurrence of CD (Division Sign-Off)
Division of General, Restorativ
and Neurological Devices
510(k) Number K060361