(60 days)
Not Found
No
The summary describes a laser handpiece for dermatological procedures and does not mention any AI or ML capabilities.
Yes
The device is intended for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue, which are therapeutic interventions to treat conditions like wrinkles, lesions, and dyschromia.
No
The device's intended use is for dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue, such as treatment of wrinkles, lesions, and vascular dyschromia. This describes therapeutic applications, not diagnostic ones.
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 clearly indicates a physical hardware component, 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 "dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue." This describes a therapeutic or surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a laser system with a handpiece used for direct application to the skin. This is consistent with a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat tissue, which falls outside the scope of an IVD.
N/A
Intended Use / Indications for Use
The Erbium Fractional Handpiece 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, pigmented lesions, and vascular dyschromia.
Product codes
GEX
Device Description
The Erbium Fractional 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
Not Found
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 Erbium Fractional are substantially equivalent to its predicate devices based on the data provided in premarket notification. Thus, it does not result in additional safety or effectiveness information.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K071768, K071152, K063571, K080244, K080915
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
FEB 2-7 2009
510(k) Summary Erbium Fractional Handpiece
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. SUBMITTER'S INFORMATION
Palomar Medical Technologies, Inc. NAME:
82 Cambridge Street ADDRESS: Burlington, MA 01803 Phone: (781) 993-2300 Fax: (781) 993-2330
Sharon Timberlake, MSHS, RAC, CCRA CONTACT: Director of Regulatory Affairs
DATE PREPARED: February 5, 2009
2. DEVICE INFORMATION
Erbium Fractional Handpiece TRADE/PROPRIETARY NAME:
Dermatological Erbium Laser Common/Usual Name:
Laser surgical instrument for use in general and CLASSIFICATION NAME: plastic surgery and in dermatology (21 CFR § 878.4810)
GEX Product Code:
PREDICATE DEVICES 3.
Palomar Medical Technologies, Inc. Palomar Erbium Fractional Handpiece K071768
Palomar Medical Technologies, Inc. Palomar Erbium Handpiece K071152, K063571
Palomar Medical Technologies, Inc. Lux1540 Fractional Handpiece K080244
1
083900
Reliant Technologies. Inc. Fraxel III SR Laser System (Fraxel Re:Pair™) K080915
INTENDED USE 4.
The Erbium Fractional Handpiece 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, pigmented lesions, and vascular dyschromia.
న్. DEVICE DESCRIPTION
The Erbium Fractional Handpiece attaches to the StarLux Pulsed Light and Laser The complete system consists of a cart, system console, chiller, a Systems. footswitch, and a handpiece.
PERFORMANCE DATA 6.
The specifications and indications for use of the Erbium Fractional are substantially equivalent to its predicate devices based on the data provided in Thus, it does not result in additional safety or premarket notification. effectiveness information.
SUBSTANTIAL EQUIVALENCE 7.
The Erbium Fractional Handpiece is substantially equivalent to its predicate devices when used according to its intended use. The information that is provided in this premarket notification demonstrates that the Erbium Fractional 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 & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
ood and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Palomar Medical Technologies, Inc. % Sharon Timberlake, MSHS, RAC, CCRA 82 Cambridge Street Burlington, Massachusetts
FEB 2 7 2009
Re: K083900
Trade/Device Name: Erbium Fractional 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: December 24, 2008 Received: December 29, 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 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.
3
Page 2 - Sharon Timberlake, MSHS, 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. N. Mulheran
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _KO8 3 900
Device Name: Erbium Fractional Handpiece
Indications for Use:
The Erbium Fractional Handpiece 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, pigmented lesions, and vascular dyschromia.
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)
Milne Bylin for mxm
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
Page 1 of 1
510(k) Number K083900
PALOMAR MEDICAL TECHNOLOGIES, INC. TRADITIONAL 510(K): ERBIUM FRACTIONAL HANDPIECE