(76 days)
Not Found
Not Found
No
The document describes a laser system with an embedded processor for control, but there is no mention of AI or ML capabilities, image processing, or data sets for training or testing.
Yes
The device is indicated for surgical incision, excision, vaporization, ablation, and coagulation of soft tissue, as well as laser-assisted lipolysis, which are therapeutic procedures.
No
The device is described as a laser system for surgical procedures like incision, excision, vaporization, and ablation of soft tissue, as well as laser-assisted lipolysis. Its function is to perform therapeutic actions, not to diagnose conditions.
No
The device description explicitly states it consists of a console, optical fiber delivery system, and footswitch, which are hardware components.
Based on the provided information, the PowerLipo Laser System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures involving the incision, excision, vaporization, ablation, and coagulation of soft tissue, as well as laser-assisted lipolysis. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a laser system with a console, fiber delivery system, and footswitch, designed for delivering laser energy for surgical purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living organism) to analyze samples and provide diagnostic information. The PowerLipo Laser System is an in vivo (within the living organism) surgical device.
N/A
Intended Use / Indications for Use
The PowerLipo Laser System is indicated for use the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The PowerLipo is further indicated for laser assisted lipolysis.
Product codes
GEX
Device Description
The PowerLipo Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the heart of the PowerLipo Laser System and contains the Nd-YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the FND display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
None presented.
Description of the test set, sample size, data source, and annotation protocol
None presented.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
OCT 0 8 2008
510(k) Summary for the Lutronic Corporation PowerLipo Laser System 〈〈▽ 8 2 09 b
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
| Submitter: | Lutronic Corporation
#403-2,3,4, Ilsan Technotown
1141-1 Baeksok-Dong, Ilsan-Gu
Goyang-Si, Gyeonggi-Do, 410-722
Republic of Korea |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maureen O'Connell
O'Connell Regulatory Consultants, Inc.
5 Timber Lane
North Reading, MA 01864
Telephone: 978-207-1245
Fax: 978-824-2541 |
| Summary Preparation Date: | July 21, 2008 |
- Names
| Device Name: | PowerLipo Laser System |
|---|---|
| Trade Name: | PowerLipo |
| Classification Name: | Laser Instrument, Surgical, Powered |
| Product Code: GEX | |
| Panel: General & Plastic Surgery |
3. Predicate Devices
The PowerLipo Laser System is substantially equivalent to a combination of the SmartLipo Laser System, the SmartLipo Multiwavelength Laser System, the Cynosure YAG MIR II Laser and the CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser.
1
4. Device Description
The PowerLipo Laser System consists of a self-contained console, an optical fiber delivery system and a footswitch. The system console is the heart of the PowerLipo Laser System and contains the Nd-YAG optical system, laser system control, fiber delivery system with handpiece, system control module with an embedded processor, and power supply module. The main console also includes a key switch used to turn the power on and off, an emergency stop push button that quickly de-energizes the system in emergency situations, and the FND display.
5. Indications for Use
The PowerLipo Laser System is indicated for use the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The PowerLipo is further indicated for laser assisted lipolysis.
6. Performance Data
None presented.
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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 0 8 2008
Lutronic Corporation % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell 5 Timber Lane North Reading, MA 01864
Re: K082096
Trade/Device Name: PowerLipo Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Instrument, Surgical, Powered Regulatory Class: Class II Product Code: GEX Dated: July 21, 2008 Received: July 24, 2008
Dear Ms. O'Connell:
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
3
Page 2 -- Ms. Maureen O'Connell
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. 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) 276-0120. 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 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 Wilkerson
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): | K082096 |
PowerLipo Laser System Device Name:
Indications for Use:
The PowerLipo Laser System in indicated for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The PowerLipo is further indicated for laser assisted lipolysis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (Part 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)
Mithe oyl formxn
Page 1 of 1
(Division Sign-Jia) Division of General, Restorative, and Neurological Devices
510(k) Number K082096