(95 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts, and the device description is purely hardware-based.
Yes
The "Intended Use / Indications for Use" section states the device is "intended for treatment of periorbital wrinkles," which indicates a therapeutic purpose.
No
The intended use explicitly states that this device is intended for "treatment of periorbital wrinkles," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly lists hardware components (handpiece, base, power cord, charger, and pretreatment gel), indicating it is 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 is "treatment of periorbital wrinkles." This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The components listed (handpiece, base, power cord, charger, pretreatment gel) are consistent with a device that applies energy or a substance to the body for treatment, not for analyzing biological samples.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with IVD devices.
Therefore, the LOI System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LOI System is an over-the-counter device intended for treatment of periorbital wrinkles.
Product codes
OHS, GEX, ONG
Device Description
The LOI System is composed of a handpiece, base, power cord, charger, and pretreatment gel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periorbital
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter
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 data was collected in multiple studies to support the safety and effectiveness of the LOI System for over-the-counter use. The clinical studies demonstrated that the LOI System functions as intended and within an acceptable safety profile.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
1090525
JUN - 1 2009
510(k) Summary LOI System
This 510(k) summary is being submitted in accordance with 21 CFR 807.92
1. SUBMITTER'S INFORMATION
NAME: Palomar Medical Technologies, Inc.
82 Cambridge Street ADDRESS: Burlington, MA 01803 Phone: (781) 993-2300 Fax: (781) 993-2330
Contact: Sharon Timberlake, MSHS, RAC, CCRA Director of Regulatory Affairs
DATE PREPARED: February 24, 2009
2. DEVICE INFORMATION
TRADE/PROPRIETARY NAME: LOI System
COMMON/USUAL NAME: Light Based System
CLASSIFICATION NAME: Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR §878.4810)
Product Code:
OHS, GEX
3. PREDICATE DEVICES
Photo Therapeutics, Inc. Omnilux New-UTM K072459
Light Biosciences, LLC GentleWaves® Consumer LED Photomodulation Device K062991
1
Reliant Technologies, Inc. Fraxel Laser System (Fraxel SR1500, Re:store™) K070284
INTENDED USE 4.
The LOI System is an over-the-counter device intended for treatment of periorbital wrinkles.
5. DEVICE DESCRIPTION
The LOI System is composed of a handpiece, base, power cord, charger, and pretreatment gel.
6. PERFORMANCE & CLINICAL DATA
The device complies with the following U.S. Food and Drug Administration performance standards: 21 CFR §1040.10 & 1040.11. Clinical data was collected in multiple studies to support the safety and effectiveness of the LOI System for over-the-counter use. The clinical studies demonstrated that the LOI System functions as intended and within an acceptable safety profile.
7. SUBSTANTIAL EQUIVALENCE
The LOI System is substantially equivalent to its predicate devices when intended for use for treatment of periorbital wrinkles. The data in this 510(k) notification demonstrate that the LOI System shares the same intended use, similar design features and functional features, and therefore is substantially equivalent to its predicate devices.
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 consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2009
Palomar Medical Products, Incorporated % Ms. Sharon Timberlake 82 Cambridge Street Burlington, Massachusetts 01803
Re: K090525
Trade/Device Name: LOI System 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: ONG Dated: April 24, 2009 Received: April 27, 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
3
· Page 2-Ms. Sharon Timberlake
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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/md:/.
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,
M U
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: LQI System
Indications for Use:
The LOI System is an over-the-counter device intended for treatment of periorbital wrinkles.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (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 R.P. Oyler-Bernan
(Division Sign-Off) (Division Sign-On), Orthopedic, and Restorative Devices
510(k) Number K090525
Page 1 of 1
PALOMAR MEDICAL TECHNOLOGIES, INC. TRADITIONAL 510(K): LOI SYSTEM