(97 days)
Not Found
No
The summary describes a laser system with standard components and does not mention any AI or ML capabilities.
Yes
The device is indicated for "laser-assisted lipolysis," which is a medical procedure aimed at treating a health condition (unwanted fat), thus classifying it as a therapeutic device.
No
The device is described as a surgical laser system indicated for laser-assisted lipolysis, which is a therapeutic procedure, not a diagnostic one. It removes fat rather than identifying a condition.
No
The device description explicitly states it consists of a cabinet housing hardware components like a power supply, cooling system, microcontroller, laser, foot switch, and fiber optic. This is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "laser-assisted lipolysis," which is a surgical procedure performed on a patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose diseases or conditions.
- Device Description: The description details a surgical laser system with components like a power supply, cooling system, laser, foot switch, fiber optic, and microcannula setup. These are all components of a device used for direct treatment on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, diagnostic purposes, or any of the typical characteristics associated with IVD devices.
Therefore, the CoolTouch Model NS160 CoolLipo Nd: Y AG Surgical Laser is a therapeutic surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cooltouch NS160 CoolLipo is indicated for laser-assisted lipolysis.
In addition to previously cleared indications for use, the CoolTouch Model NS160 CoolLipo Nd: Y AG Surgical Laser is indicated for laser-assisted lipolysis.
Product codes
79-GEX
Device Description
CoolTouch CoolLipo The NS160 Nd: YAG Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and the fiber optic for delivery of the laser energy with microcannula setup.
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
Nonclinical performance data produced results that indicate the Cooltouch NS160 CoolLipo laser system is effective for laser-assisted lipolysis.
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.
0
Premarket Notification 510(k) Summary K072751 (As Required by 21 CFR 807.93)
This 510(k) Summary of safety and effectiveness for the New Star Model CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser system is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(k) summary.
Submitter: New Star Lasers, Inc. d.b.a. CoolTouch, Inc. Address: 9085 Foothills Boulevard Roseville, CA 95747 !JAN 0 2 2007 Contact Person: Natalie Vollrath Quality Assurance Manager Telephone/Fax/Email: (916) 677-1912 - Phone (916) 677-1901 - Fax nvollrath@newstarlasers.com - Email Date prepared: October 26, 2007 Device Trade Name: CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser Common Name: Nd: YAG Surgical Laser Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR §878.4810 Legally Marketed Predicate Cynosure SmartLipo Nd:YAG laser system Devices: K062321 Device Description: CoolTouch CoolLipo The NS160 Nd: YAG Surgical Laser System is an Nd:YAG laser producing laser emission at 1320 nm. The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser,
foot switch, and the fiber optic for delivery of the
The Cooltouch NS160 Cool Lipo is indicated for
laser energy with microcannula setup.
laser-assisted lipolysis.
Intended Use:
intended Use:
1
Comparison: The Cooltouch NS160 CoolLipo has the same indication for use, the same principle of operation, and essentially the same wavelength and pulse energy rate as the predicate device.
None
Nonclinical performance data produced results that indicate the Cooltouch NS160 CoolLipo laser system is effective for laser-assisted lipolysis.
Clinical Performance Data:
Nonclinical Perfomance Data
Conclusion:
The CoolTouch NC160 CoolLipo Nd:YAG Surgical Laser System is substantially equivalent to the predicate device and is indicated for laserassisted lipolysis.
Additional Information:
None requested at this time.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Public Health Service
JAN 0 2 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
New Star Lasers, Inc. % Ms. Natalie R. Vollrath Quality Assurance Manager 9085 Foothills Boulevard Roseville, California 95747
Re: K072751
Trade/Device Name: CoolTouch NS160 CoolLipo Nd: YAG Laser 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: GEX Dated: September 26, 2007 Received: September 27, 2007
Dear Ms. Vollrath:
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. Natalie R. Vollrath
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 Protmarket, 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 M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number
Pending 人07 27 51
Device Name
CoolTouch NS160 CoolLipo Nd:YAG Laser System
Indications for Use
In addition to previously cleared indications for use, the CoolTouch Model NS160 CoolLipo Nd: Y AG Surgical Laser is indicated for laser-assisted lipolysis.
FOR M. MELKERSON
(Division Sign-Off)> Division of General, Restorative, and Neurological Devices
1072751 510(k) Number_
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)
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