(9 days)
No
The summary does not mention AI, ML, or related concepts, and the device description is focused on hardware components and basic software.
Yes
The device is indicated for "laser assisted lipolysis," which is a medical procedure aimed at treating a condition (excess fat) through a physical intervention (laser).
No
The Palomar Aspire™ Laser Platform is indicated for laser-assisted lipolysis, which is a treatment procedure, not a diagnostic one. There is no mention of diagnostic functions like image analysis or detection of conditions.
No
The device description explicitly lists multiple hardware components (cart, power supply, footswitch, cooling system, handpiece) in addition to software.
Based on the provided information, the Palomar Aspire™ Laser Platform is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "laser assisted lipolysis." This is a surgical or cosmetic 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 system for delivering laser energy, not for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Palomar Aspire™ Laser Platform's function is to perform a physical procedure on the patient.
N/A
Intended Use / Indications for Use
The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.
Product codes
GEX
Device Description
The Palomar Aspire™ Laser Platform is a small transportable system which includes a cart, power supply, software, user interface panel, footswitch, cooling system and 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
The review of the technical characteristics, indications for use, risk analysis information, and verification and validation information provided demonstrate that the modified Palomar Aspire™ Laser Platform is substantially equivalent to its predicate device. The Palomar Aspire™ Laser Platform is as safe and effective as its predicate devices. The information provided in this application demonstrates the Palomar Aspire™ Laser Platform shares the same indications for use, similar technological characteristics and principals of operation. Therefore, the Palomar Aspire™ Laser Platform substantially equivalent to its predicate devices.
Key Metrics
Not Found
Predicate Device(s)
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.
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510(K) Summary
MAY 2 9 2008
This 510(k) Summary is being submitted in accordance with 21 CFR 807.92
| Applicant: | Palomar Medical Technologies, Inc.
82 Cambridge St.
Burlington, MA 01803 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sharon Timberlake, MSHS, RAC, CCRA
Director of Regulatory Affairs
(781) 993-2414 |
| Preparation Date: | May 19, 2008 |
| Device Trade Name: | The Palomar Aspire™ Laser Platform |
| Common Name: | Medical laser system |
| Classification Name: | Laser surgical instrument for use in General and Plastic Surgery
and Dermatology (21 CFR 878.4810) |
| Product Code: | 79 GEX |
| Predicate Device: | The Palomar Aspire™ Laser Platform
Palomar Medical Technologies, Inc.
K080567 |
| System Description: | The Palomar Aspire™ Laser Platform is a small transportable
system which includes a cart, power supply, software, user
interface panel, footswitch, cooling system and handpiece. |
| Intended Use: | The Palomar Aspire™ Laser Platform is indicated for laser
assisted lipolysis. |
| Performance: | The review of the technical characteristics, indications for
use, risk analysis information, and verification and validation
information provided demonstrate that the modified Palomar
Aspire™ Laser Platform is substantially equivalent to its
predicate device. |
| Substantial Equivalence: | The Palomar Aspire™ Laser Platform is as safe and effective
as its predicate devices. The information provided in this
application demonstrates the Palomar Aspire™ Laser
Platform shares the same indications for use, similar
technological characteristics and principals of operation.
Therefore, the Palomar Aspire™ Laser Platform substantially
equivalent to its predicate devices. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2008
Palomar Medical Technologies, Inc. % Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs 82 Cambridge Street Burlington, Massachusetts 01803
Re: K081416
Trade/Device Name: Palomar Aspire™ Laser Platform 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 19, 2008 Received: May 20, 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
2
Page 2 - Sharon Timberlake, MSHS, RAC, CCRA
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 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. 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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Indications for Use
510(k) Number (if known): _ KO8 14160
Device Name: Palomar Aspire™ Laser Platform
Indications for Use:
The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.
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)
Nel Rp. Opl - fr min
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K081416
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