(210 days)
Not Found
Not Found
No
The description focuses on the laser technology and its components, with no mention of AI or ML.
Yes
The device is indicated for use in surgical procedures for the coagulation and hemostasis of vascular lesions and soft tissue, which is a therapeutic purpose.
No
The device is described as a surgical laser used for coagulation and hemostasis of vascular lesions and soft tissue, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it consists of a cabinet housing hardware components (power supply, cooling system, microcontroller, laser), fiber optics, and a handpiece, indicating it 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 clearly states "surgical procedures for the coagulation and hemostasis of vascular lesions and soft tissue." This describes a therapeutic or surgical intervention performed directly on the patient's body.
- Device Description: The description details a laser system used for surgical procedures, not for analyzing samples (like blood, urine, or tissue) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The Laser Aesthetics COOLTOUCH "V" Nd:YAG laser is indicated for use in surgical procedures for the coagulation and hemostasis of vascular lesions and soft tissue.
Product codes
79-GEX
Device Description
The Laser Aesthetics COOLTOUCH "V" Nd:YAG Surgical Laser is an Nd:YAG laser producing laser emission at 1064nm. The laser consists of three interconnected sections: The cabinet which houses the power supply, the cooling system, the microcontroller and the laser, the fiber optics and the 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Laser Aesthetics NS 130 "CoolTouch" Nd:YAG Laser System, HGM Veinlase Nd:YAG Laser System, Laserscope Orion Nd:YAG Laser System
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
K 983984
Attachment I 510(K) Summary COOL TOUCH "V" Nd: Y AG Laser System
This 510(K) Summary of safety and effectiveness for the COOLTOUCH "V" Nd:YAG Surgical Laser This JIV(I') builting or sailing with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.
| Applicant: | Laser Aesthetics | |
|---|---|---|
| Address: | 11802 Kemper Road | |
| Auburn, CA 95603 | ||
| Contact Person: | Jonathan M. Baumgardner | |
| Telephone: | (916) 823-1434 | |
| Fax (916) 823-1446 | ||
| Preparation Date: | 11-6-98 | |
| Device Trade Name: | COOLTOUCH "V" Nd:YAG Surgical Laser | |
| Common Name: | Nd:YAG Pulsed Surgical Laser | |
| Classification Name: | Instrument, Surgical, Powered, laser | |
| 79-GEX | ||
| 21 CFR 878-48 | ||
| Legally Marketed Predicate Device: | Laser Aesthetics NS 130 "CoolTouch" Nd:YAG Laser | |
| System, HGM Veinlase Nd:YAG Laser System, Laserscope | ||
| Orion Nd:YAG Laser System | ||
| Description of the Laser Aethetics | ||
| COOLTOUCH "V" Nd:YAG Surgical | ||
| Laser: | The Laser Aesthetics COOLTOUCH "V" Nd:YAG Surgical | |
| Laser is an Nd:YAG laser producing laser emission at | ||
| 1064nm. The laser consists of three interconnected sections: | ||
| The cabinet which houses the power supply, the cooling | ||
| system, the microcontroller and the laser, the fiber optics and | ||
| the handpiece. | ||
| Intended use of the Laser Aesthetics | ||
| COOLTOUCH "V" Nd:YAG Surgical | ||
| Laser: | The Laser Aesthetics COOLTOUCH "V" Nd:YAG laser is | |
| indicated for use in surgical procedures for the coagulation | ||
| and hemostasis of vascular lesions and soft tissue. | ||
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | None | |
| Conclusion: | The Laser Aesthetics COOLTOUCH "V" Nd:YAG Surgical | |
| Laser System is substantially equivalent to other existing | ||
| surgical laser systems in commercial distribution. | ||
| Additional Information: | None requested at this time |
1
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 1999 JUN
Mr. Jonathan M. Baumgardner Project Manager Laser Aesthetics, Inc. 11802 Kemper Road Auburn, California 95603
Re:
K983984 Trade Name: CoolTouch "V" Nd: YAG Laser Regulatory Class: II Product Code: GEX Dated: March 5, 1999 Received: March 9, 1999
Dear Mr. Baumgardner:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 – Mr. Jonathan M. Baumgardner
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATION FOR USE STATEMENT
510(k) Number: __ K_983984
Device Name: Laser Aesthetics Nd:YAG Surgical Laser Model COOLTOUCH "V"
Indications for Use:
The Laser Aesthetics Nd:YAG Surgical Laser Model COOLTOUCH "V" is indicated for the coagulation and hemostasis of vascular lesions and soft tissue.
(Please do not write below this line - Continue on another page if needed)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K983984 |
| Prescription Use | X | OR | Over-the-Counter Use |
|---|---|---|---|
| (per 21 CFR 801 109) |