(141 days)
Not Found
No
The document describes a laser handpiece and system for dermatological procedures, with no mention of AI or ML capabilities in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for dermatological procedures requiring coagulation of soft tissue, skin resurfacing, and treatment of melasma, acne scars, and surgical scars, which are therapeutic applications.
No
The device's intended use is for dermatological procedures requiring coagulation of soft tissue, skin resurfacing, and the treatment of various scars and melasma, not for diagnosing conditions.
No
The device description explicitly states it is a "Handpiece" that "attaches to the StarLux Pulsed Light and Laser Systems" and is part of a "complete system consists of a cart, system console, chiller, a footswitch, and a handpiece." This indicates it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "dermatological procedures requiring: Coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars." These are all procedures performed directly on the patient's skin for therapeutic or cosmetic purposes.
- Device Description: The description details a laser handpiece that attaches to a system for delivering light energy to the skin. This is consistent with a device used for external treatment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition. IVDs are designed to provide information about a patient's health status through the examination of such samples.
Therefore, the Palomar Lux1540 handpiece is a therapeutic device used for treating skin conditions, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Palomar Lux1540 handpiece is intended for use in dermatological procedures requiring the coagulation of soft tissue, skin resurfacing procedures, mclasma, acne scars, and surgical scars.
Product codes
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K060301, K061652, K070284, K062303, K042319
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
pg 1 of 2
510(k) Summary Lux1540 Handpiece
JUN 2 0 2008
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
SUBMITTER'S INFORMATION 1.
| NAME: | Palomar Medical Technologies, Inc. |
|---|---|
| ADDRESS: | 82 Cambridge Street |
| Burlington, MA 01803 | |
| Phone: (781) 993-2300 | |
| Fax: (781) 993-2330 | |
| CONTACT: | Sharon Timberlake, RAC, CCRA |
| Director of Regulatory Affairs |
DATE PREPARED: June 18, 2008
DEVICE INFORMATION 2.
| Trade/Proprietary Name: | Palomar Lux1540 Handpiece |
|---|---|
| COMMON/USUAL NAME: | Lux1540 |
| 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 Handpiece K060301 & K061652
Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store™) K070284, K062303, K042319
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K080244 pg 2 of 2
4. INTENDED USE
The Palomar Lux1540 handpiece is intended for use in dermatological procedures requiring the coagulation of soft tissue, skin resurfacing procedures, mclasma, acne scars, and surgical scars.
5. 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.
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
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, MA 01803
JUN 2 0 2008
Re: K080244 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: May 29, 2008 Received: May 30, 2008
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. Iisting 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 (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.
3
Page 2 - Ms. Sharon Timberlake, RAC, CCRA
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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080244
pg 1 of 1
Indications for Use
510(k) Number (if known): K080244
Device Name: Palomar Lux 1 540 Handpicce
Indications for Use:
The Palomar Lux1540 handpiece is intended for use in dermatological procedures requiring:
Coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil RBQ,L for xkm
Division of General, Restorative, and Neurological Devices
510(k) Number K080244