(78 days)
Not Found
No
The summary describes a laser system with a microcontroller and standard components, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML development.
Yes
The device is indicated for "laser-assisted lipolysis," which is a medical procedure aimed at treating a health condition (excess fat) and restoring a healthier body state.
No
The device is a surgical laser system used for laser-assisted lipolysis, which is a treatment or therapy, not a diagnostic procedure.
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 indicates it is a hardware device, not software-only.
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 directly on the patient's body. IVDs are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Description: The description details a surgical laser system used for delivering energy to tissue. This is consistent with a surgical device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the CoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laser is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
In addition to previously cleared indications for use, the CoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laser is indicated for laser-assisted lipolysis.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The CoolTouch LC215/CoolLipo 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Perfomance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/12 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of an eagle with outstretched wings, symbolizing protection and care. The words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The word "DEPARTMENT" is written below the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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New Star Lasers, Inc. % Ms. Natalie R. Vollrath Quality Assurance Manager 9085 Foothills Boulevard Roseville, California 95747
APR 1 0 2008
Re: K080163
Trade/Device Name: CoolTouch LC215/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: January 22, 2008 Received: January 23, 2008
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
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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 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. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number
이다. 주
| Device Name | CoolTouch LC215/CoolLipo Nd:YAG Laser System |
|---|---|
| Indications for | |
| Use | In addition to previously cleared indications for use, the |
| CoolTouch Model LC215/CoolLipo Nd:YAG Surgical Laser | |
| 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Page 1 of 1
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Appendix 2 510(k) Summary
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Premarket Notification 510(k) Summary (As Required by 21 CFR 807.93)
This 510(k) Summary of safety and effectiveness for the New Star Model CoolTouch LC21/CoolLipoo This JTQ(K) Surgical Laser systems 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 | |
| Contact Person: | Natalie Vollrath |
| Quality Assurance Manager | |
| Telephone/Fax/Email: | (916) 677-1912 - Phone |
| (916) 677-1901 - Fax | |
| nvollrath@newstarlasers.com - Email | |
| Date prepared: | January 22, 2008 |
| Device Trade Name: | CoolTouch LC215/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 | |
| Devices: | CoolTouch NS160 CoolLipo Nd: YAG laser |
| system (K072751) | |
| CoolTouch LC215 Nd:YAG laser system | |
| (K072424) | |
| Device Description: | The CoolTouch LC215/CoolLipo 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. |
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| Intended Use: | In addition to previously cleared indications, the
Cooltouch LC215/CoolLipo is indicated for laser-
assisted lipolysis. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The Cooltouch LC215/CoolLipo has the same
principle of operation, the same wavelength and
essentially the same pulse energy rate as the
predicate devices. |
| Nonclinical Perfomance Data | None |
| Clinical Performance Data: | None |
| Conclusion: | The CoolTouch LC215/CoolLipo Nd:YAG
Surgical Laser System is substantially equivalent
to the predicate devices and is indicated for laser-
assisted lipolysis. |
| Additional Information: | None requested at this time. |