K Number
K062210
Device Name
COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160
Date Cleared
2006-09-25

(55 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CoolTouch LC160 CTEV Nd:YAG Laser System with the JouleTraker accessory is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities.
Device Description
The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of a cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic. Accessories include a footswitch and a fiber optic pull-back device, the JouleTraker.
More Information

Not Found

No
The document does not mention AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses on the laser technology and its accessories.

Yes
The device is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, which falls under therapeutic use.

No
The device is described as a laser system indicated for the treatment of varicose veins and not for diagnosing any conditions.

No

The device description clearly states it is a laser system with hardware components (cabinet, power supply, cooling system, microcontroller, laser, fiber optic, footswitch, and fiber optic pull-back device).

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the treatment of reflux in saphenous veins, which is a therapeutic procedure performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
  • Device Description: The device is a laser system designed to deliver energy to tissue. This is consistent with a therapeutic device, not a diagnostic one that analyzes biological samples.
  • Anatomical Site: The device is used on the great and small saphenous veins, which are internal structures within the patient's body. IVDs work with samples taken from the body.

The description clearly indicates a device used for a medical treatment procedure, not for analyzing biological samples in a laboratory setting.

N/A

Intended Use / Indications for Use

The CoolTouch LC160 CTEV Nd:YAG Laser System is for treatment of reflux of the great and small saphenous veins associated with varicose veins and varicosities.

The CoolTouch LC160 CTEV Nd:YAG Laser System with the JouleTraker accessory is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities.

Product codes

GEX

Device Description

The CoolTouch Nd:YAG Laser Systems are Nd:YAG lasers producing laser emission at 1320 nm. The lasers consist of a cabinet, which houses the power supply, cooling system, microcontroller and the laser, and the fiber optic. Accessories include a footswitch and a fiber optic pull-back device, the JouleTraker.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

great and small saphenous veins

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: No clinical performance data was submitted.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

CoolTouch Inc. Model CTEV (NS160) Nd:YAG Laser Systems with Trac Back accessory

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

K06 2210

CoolTouch Incorporated Model LC160 CTEV Nd:YAG Laser Systems 510(k) Premarket Notification 510(k) SUMMARY

Submitter:CoolTouch Incorporated
Address:9085 Foothills Boulevard
Roseville, CA 95747
Contact Person:Donald V. Johnson
Vice-President of Operations
Telephone:(916) 677-1912
Facsimile:(916) 677-1901
Date Prepared:July 31, 2006
Device Trade Name:CoolTouch Corporation Model LC160 CTEV Nd:YAG
Laser Systems with JouleTraker Accessory
Common Name:Nd: YAG Surgical Laser
Classification Name:Laser Surgical Instrument.
21 C.F.R. § 878.4810
Legally Marketed Predicate
Devices:CoolTouch Inc. Model CTEV (NS160) Nd:YAG Laser
Systems with Trac Back accessory
Description of the CoolTouch
Nd:YAG Laser Systems:The CoolTouch Nd:YAG Laser Systems are Nd:YAG
lasers producing laser emission at 1320 nm. The lasers
consist of a cabinet, which houses the power supply,
cooling system, microcontroller and the laser, and the
fiber optic. Accessories include a footswitch and a fiber
optic pull-back device, the JouleTraker.
Intended use of CoolTouch
Nd:YAG Laser Systems:The CoolTouch LC160 CTEV Nd:YAG Laser System is
for treatment of reflux of the great and small saphenous
veins associated with varicose veins and varicosities.

1

K062210

Nonclinical Performance Data:None
Clinical Performance Data:No clinical performance data was submitted.
Conclusion:The CoolTouch LC160 CTEV Nd:YAG Laser Systems
are indicated for treatment of reflux of the great and
small saphenous veins associated with varicose veins
and varicosities.
Additional Information:None requested at this time

(_)

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 25 2006

New Star Lasers, Inc., dba CoolTouch, Inc. % Mr. Donald V. Johnson Vice President of Operations 9085 Foothills Boulevard Roseville, California 95747

Re: K062210

Trade/Device Name: CoolTouch LC160 CTEV Nd:YAG Laser System with Joule Traker Accessory 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: July 31, 2006 Received: August 1, 2006

Dear Mr. Johnson:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf have and have 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 arior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that provise that the provisions 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 merere, maintens 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 I·DA'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 forth in the

3

Page 2 - Mr. Donald V. Johnson

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) rmarket 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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

I'd. Pato V.

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 STATEMENT

510(k) Number:

Device Name: CoolTouch LC160 CTEV Nd: YAG Laser System

Indications for Use:

The CoolTouch LC160 CTEV Nd:YAG Laser System with the JouleTraker accessory is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities.

Prescription Use ﻟﻤﺴﺮ (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)

(Division Sign (IT) Division of General, Restorative and Neurological Devices

510(k) Number (L o 62210