K Number
K061618
Device Name
COOLTOUCH, MODEL CTEV
Date Cleared
2006-09-25

(108 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CoolTouch CTEV Nd:YAG Laser System is indicated for the treatment of superficial incompetent tributary 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.
More Information

Not Found

Not Found

No
The summary describes a laser system for treating veins and does not mention any AI or ML components or functionalities.

Yes
The device is indicated for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities, which is a therapeutic intervention.

No
The device is indicated for the "treatment of superficial incompetent tributary veins associated with varicose veins and varicosities," which describes a therapeutic rather than diagnostic function.

No

The device description clearly outlines hardware components including a cabinet housing power supply, cooling system, microcontroller, laser, fiber optic, footswitch, and fiber optic pull-back device. This is not a software-only 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 superficial incompetent tributary veins using a laser system. IVDs are used to diagnose diseases or conditions by examining samples from the human body (like blood, urine, tissue).
  • Device Description: The device is a laser system that emits light at a specific wavelength. This is a therapeutic device, not a diagnostic one.
  • No mention of biological samples: There is no indication that this device interacts with or analyzes biological samples.

Therefore, the CoolTouch CTEV Nd:YAG Laser System is a therapeutic device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The CoolTouch CTEV Nd:YAG Laser System is indicated for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities.

Product codes (comma separated list FDA assigned to the subject device)

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

superficial incompetent tributary 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)

Clinical Performance Data: Clinical results were submitted that indicate that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of vein reflux associated with varicose veins and varicosities.

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.

CoolTouch Inc. Model CTEV (NS-160) Nd:YAG Laser Systems

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.

0

K 061618

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

SEP 2 5 2006

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:May 31, 2005
Device Trade Name:CoolTouch Corporation Model CTEV Nd:YAG Laser
Systems
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 (NS-160) Nd:YAG Laser
Systems
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.
Intended use of CoolTouch
Nd: YAG Laser Systems:The CoolTouch CTEV Nd:YAG Laser System is
indicated for the treatment of superficial incompetent
tributary veins associated with varicose veins and
varicosities.
SEP 25 2

. . . . .

1

Nonclinical Performance Data:None
Clinical Performance Data:Clinical results were submitted that indicate that the
CoolTouch Nd:YAG Laser Systems are effective in the
treatment of vein reflux associated with varicose veins
and varicosities.
Conclusion:The CoolTouch CTEV Nd:YAG Laser System is
indicated for the treatment of superficial incompetent
tributary veins associated with varicose veins and
varicosities.
Additional Information:None requested at this time

020

2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2006

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

Re: K061618

Trade/Device Name: CoolTouch CTEV 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: Class II Product Code: GEX Dated: August 16, 2006 Received: August 17, 2006

Dear Mr. Johnson:

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 for associated or to May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimered prices 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 r ou may, ateres 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 or any I 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 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.

3

Page 2 -- Mr. Donald V. Johnson

This letter will allow you to begin marketing your device as described in your Section 510(k) I ma lotter witification. The FDA finding of substantial equivalence of your device to a legally promated 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 If you attire 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 other general 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,

Barbara Buchner

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

4

INDICATION FOR USE STATEMENT

K061618 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name: CoolTouch CTEV Nd: YAG Laser System

Indications for Use:

The CoolTouch CTEV Nd:YAG Laser System is indicated for the treatment of superficial incompetent tributary veins associated with varicose veins and varicosities.

Prescription Use
(per 21 CFR 801.109)

ાર

Over-the-Counter Use_

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

barbare Bnchum

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K0611618

0004