(297 days)
Not Found
No
The document describes a laser handpiece and system for skin treatments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The focus is on the laser technology itself and its intended uses.
Yes
The device is used for medical treatments like skin resurfacing, melasma, and scar treatment, which are therapeutic interventions.
No
Explanation: The device is indicated for treatment procedures such as coagulation, skin resurfacing, and treatment of melasma, striae, acne scars, and surgical scars. There is no mention of diagnosis.
No
The device description explicitly states it is a handpiece that attaches to a system consisting of hardware components (cart, console, chiller, footswitch). It is a physical medical device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The Palomar Lux1540 Handpiece is a laser handpiece used for treating various skin conditions and performing procedures directly on the patient's body (in vivo). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes therapeutic and cosmetic procedures performed on the skin and soft tissue.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as sample analysis, detection of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, the Palomar Lux1540 Handpiece is a therapeutic/surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Palomar Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures, treatment of melasma and striae, and treatment of acne scars and surgical scars.
The Palomar Lux1540™ Handpiece is intended for use in: Coagulation of soft tissue; Skin resurfacing procedures; Treatment of melasma and striae; Treatment of acne scars and surgical scars.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Lux1540 Handpiece attaches to the StarLux Pulsed Light and Laser Systems. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue; skin
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 specifications and indications for use of the Lux1540 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) premarket notification.
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.
K080244, K070284, K080006, K082033
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
510(k) Summary Lux1540™ Handpiece
Kog 0195
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
SUBMITTER'S INFORMATION 1.
| NAME: | Palomar Medical Technologies, Inc. | NOV 20 2009 |
|---|---|---|
| ADDRESS: | 82 Cambridge Street | |
| Burlington, MA 01803 | ||
| Phone: (781) 993-2300 | ||
| Fax: (781) 993-2330 | ||
| CONTACT: | Sharon Timberlake, MSHS, RAC, CCRA | |
| Director of Regulatory Affairs |
DATE PREPARED: January 26, 2009
2. DEVICE INFORMATION
| TRADE/PROPRIETARY NAME: | Palomar Lux1540™ Fractional Laser Handpiece |
|---|---|
| COMMON/USUAL NAME: | Lux1540, Lux1540 Handpiece |
| CLASSIFICATION NAME: | Laser surgical instrument for use in general and |
| plastic surgery and in dermatology | |
| (21 CFR § 878.4810) | |
| PRODUCT CODE: | GEX |
3. PREDICATE DEVICES
Palomar Medical Technologies, Inc. Lux1540™ Fractional Laser Handpiece K080244
Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store™) K070284
Cynosure, Inc. Affirm Family Laser with XPL Handpiece K080006
Global USA Distribution, LLC. NannoLight IPL System K082033
1
4. INTENDED USE
The Palomar Lux1540 Handpiece is intended for use in coagulation of soft tissue, skin resurfacing procedures, treatment of melasma and striae, and treatment of acne scars and surgical scars.
DEVICE DESCRIPTION న్.
The Lux1540 Handpiece attaches to the StarLux Pulsed Light and Laser Systems. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.
PERFORMANCE DATA 6.
The specifications and indications for use of the Lux1540 Handpiece are substantially equivalent to its predicate devices based on the data provided in the 510(k) premarket notification.
7. SUBSTANTIAL EQUIVALENCE
The Lux1540 Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this 510(k) premarket notification demonstrates that the Lux1540 Handpiece also shares the same technological characteristics, mechanism of action, intended use and physical properties to its predicates.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803
NOV 2 0 2009
Re: K090195
Trade/Device Name: PalomarLux 1540™ Handpiece
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in genera and plastic surgery and in dermatology
Regulatory Class: II Product Code: GEX Dated: June 23, 2009 Received: June 24, 2009
Dear Ms. Timberlake:
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 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 (OS) 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. Sharon Timberlake
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K090195 |
|---|---|
| --------------------------- | --------- |
Device Name: PalomarLux1540™ Handpiece
Indications for Use:
The Palomar Lux1540™ Handpiece is intended for use in:
Coagulation of soft tissue; Skin resurfacing procedures; Treatment of melasma and striae; Treatment of acne scars and surgical scars.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 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)
Nilser Aal for mxm
(Division Sign-off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090195
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CONFIDENTIAL