(92 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The focus is on the laser technology and its intended dermatological procedures.
Yes
The device is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue, which are procedures aimed at treating medical conditions or pathologies (e.g., wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions).
No
The device is described as being intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue, which are therapeutic actions, not diagnostic. Its purpose is to treat conditions like wrinkles and pigmented lesions, not to diagnose them.
No
The device description explicitly states that the complete platform consists of hardware components including a cart, console, chiller, and footswitch, in addition to handpieces. This indicates it is a hardware-based medical device with potential software control, 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 clearly states the device is for "dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue." This involves direct treatment of the patient's skin.
- Device Description: The description details a physical platform with handpieces that interact with the patient's tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body. This device is a therapeutic device used for direct treatment of the patient.
N/A
Intended Use / Indications for Use
The Lux1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The Lux1440 and Lux2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
Product codes
GEX, ONG
Device Description
The complete platform consists of a cart, console with an internal power supply and electronics, chiller, and a footswitch. Each handpiece individually attaches to the console via a connection port.
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)
Clinical studies were conducted to evaluate safety and effectiveness when combining either the Lux1540 and Lux2940 or the Lux1440 and Lux2940 for treatment of wrinkles, dyschromia and pigmented lesions. The specifications and indications for use of the handpieces are substantially equivalent to the predicate devices based on the data provided in Premarket Notification and comparison of the technical characteristics. Thus, these handpieces do not result in additional safety or effectiveness information.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100270, K083900, K071768, K071152, K063571, K090195, K091446, K080244, K060301, K073583
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
510(k) Summary
SEP 1 2010
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. SUBMITTER'S INFORMATION
مسمس
t
Palomar Medical Technologies, Inc. NAME:
ADDRESS: 15 Network Drive Burlington, MA 01803 Phone: (781) 993-2300 Fax: (781) 418-1169
CONTACT: Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs
DATE PREPARED: June 24, 2010
2. DEVICE INFORMATION
| TRADE/PROPRIETARY NAME: Lux 1540, Lux 1440, & Lux 2940 Handpieces |
|---|
Dermatological and cosmetic laser COMMON/USUAL NAME:
CLASSIFICATION NAME:
Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR § 878.4810)
Product Code: GEX. ONG
3. PREDICATE DEVICES
Palomar Erbium Handpiece (Lux2940 Handpiece) K100270, K083900, K071768, K071152, K063571
Palomar Medical Technologies, Inc. Lux1540 Handpiece K100270, K090195, K091446, K080244, K060301
Palomar Medical Technologies, Inc. Lux1440 Handpiece K100270, K073583, K091446
1
101506
INTENDED USE 4.
The Lux1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The Lux1440 and Lux2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
క. DEVICE DESCRIPTION
The complete platform consists of a cart, console with an internal power supply and electronics, chiller, and a footswitch. Each handpiece individually attaches to the console via a connection port.
PERFORMANCE DATA 6.
Clinical studies were conducted to evaluate safety and effectiveness when combining either the Lux1540 and Lux2940 or the Lux1440 and Lux2940 for treatment of wrinkles, dyschromia and pigmented lesions. The specifications and indications for use of the handpieces are substantially equivalent to the predicate devices based on the data provided in Premarket Notification and comparison of the technical characteristics. Thus, these handpieces do not result in additional safety or effectiveness information.
7. SUBSTANTIAL EQUIVALENCE
The Lux1540, Lux1440 and Lux2940 Handpieces are substantially equivalent to their predicate devices when used according to its intended use. This decision is based on the information that is provided in this 510(k) Premarket Notification which demonstrates that the handpieces share the same technological characteristics, mechanism of action, intended use and physical properties when compared to their predicates.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally oriented. The text is black against a white background.
1 2010
SEP
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Palomar Medical Technologies, Inc. % Ms. Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs 15 Network Drive Burlington, Massachusetts 01803
Re: K101506
Trade/Device Name: Lux1540. Lux1440 and Lux2940 Handpieces Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: Class II Product Code: GEX, ONG Dated: June 28, 2010 Received: June 29, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
3
Page 2 - Ms. Sharon Timberlake, MSHS, RAC, CCRA
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 (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.
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Chavala brehm
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
SEP 1. 2010
510(k) Number (if known):
Device Name: Lux1540, Lux1440 and Lux2940 Handpieces
Indications for Use:
The Lux 1540 and Lux2940 fractional combined treatment is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
The Lux1440 and Lux2940 fractional combined treatment is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, furrows, fine lines, textural irregularities, dyschromia and pigmented lesions.
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 CDRH, or
Barbara Buchan Dixon
(Division Sign-Off)
ion of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101506
Page 1 of 1
PALOMAR MEDICAL TECHNOLOGIES, INC. LUX1540, LUX1440 & ERBIUM FRACTIONAL HANDPIECES CONFIDENTIAL