(88 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 use in the treatment of fine lines and wrinkles, which is a therapeutic application.
No
The device is described as a laser system for treatment in dermatological and plastic surgery applications, specifically for fine lines and wrinkles. It is used for therapeutic purposes, not for diagnosing conditions.
No
The device description explicitly states it consists of hardware components: a cabinet housing power supply, cooling system, microcontroller, and laser; a fiber optic; and a handpiece.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "Dermatological and Plastic Surgery applications including use in the treatment of fine lines and wrinkles." This describes a therapeutic or cosmetic procedure performed directly on a patient's body.
- Device Description: The description details a laser system that emits light at 1320 nm and is applied via a handpiece. This is consistent with a device used for external treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to analyze samples taken from the human body to provide information about a person's health status. This laser system is used to directly treat a condition on the body.
N/A
Intended Use / Indications for Use
The CoolTouch Nd:YAG Laser Systems are indicated for use in Dermatological and Plastic Surgery applications including use in the treatment of fine lines and wrinkles.
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 three interconnected sections: The cabinet, which houses the power supply, cooling system, microcontroller and the laser, the fiber optic, 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)
Clinical trials produced results that indicated that the CoolTouch Nd:YAG Laser Systems are effective in the treatment of periorbital and perioral wrinkles. See previous related 510(k) submissions for clinical results.
The CoolTouch Nd: YAG Laser Systems are indicated for the general treatment of wrinkles.
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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ICN Phramceuticals, Inc. CoolTouch Nd:YAG Laser System Page 13
022817
ICN Pharmaceuticals, Inc. CoolTouch Nd:YAG Laser System 510(k) Premarket Notification 510(k) SUMMARY
NOV 2222002
())
| Submitter: | ICN Pharmaceuticals, Inc. |
|---|---|
| Address: | 3300 Hyland Ave. |
| Costa Mesa, CA 92626 | |
| Contact Person: | Edward F. Smith III |
| Director, Corporate Regulatory Affairs | |
| Telephone: | (714) 545-0100 X 2016 |
| Facsimile: | (714) 641-7241 |
| Date Prepared: | August 22, 2002 |
| Device Trade Name: | CoolTouch Nd:YAG Laser System |
| CoolTouch-II Nd:YAG Laser System | |
| Common Name: | Nd: YAG Pulsed Surgical Laser |
| Classification Name: | Laser Surgical Instrument. |
| 21 C.F.R. § 878.4810 | |
| Legally Marketed Predicate Device: | New Star Lasers, Inc. Model 130 Nd: YAG Surgical |
| Laser System (K962791). | |
| 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 three interconnected sections: The cabinet, | |
| which houses the power supply, cooling system, | |
| microcontroller and the laser, the fiber optic, and the | |
| handpiece. | |
| Intended use of CoolTouch | |
| Nd: Y AG Laser Systems: | The CoolTouch Nd:YAG Laser Systems are indicated |
| for use in Dermatological and Plastic Surgery | |
| applications including use in the treatment of fine lines | |
| and wrinkles. | |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | Clinical trials produced results that indicated that the |
| CoolTouch Nd:YAG Laser Systems are effective in the | |
| treatment of periorbital and perioral wrinkles. See | |
| previous related 510(k) submissions for clinical results. | |
| Conclusion: | The CoolTouch Nd: YAG Laser Systems are indicated |
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022817 2/2
for the general treatment of wrinkles.
Additional Information:
.
None requested at this time
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the serpent and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
200 Corporate Boulevaro Rockville MD 20850
ICN Pharmaceuticals, Inc. Dr. Edward F. Smith III Director, Corporate Regulatory Affairs 3300 Hyland Avenue Costa Mesa, California 92626
Re: K022817
Trade/Device Name: CoolTouch Nd: YAG and CoolTouch II Nd: YAG Laser Systems Regulation Number: 878.4810 Regulation Name: Laser surgical instrument Regulatory Class: Class II Product Code: GEX Dated: August 22, 2002 Received: August 26, 2002
Dear Dr. Smith:
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 forth in the
3
Page 2 – Dr. Edward F. Smith
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 Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Miriam C. Provost
( Celia M. Witten, Ph.D., MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ICN Phramceuticals, Inc. CoolTouch Nd: YAG Laser System Page 23
INDICATION FOR USE STATEME
510(k) Number: K022817
Device Name: ICN Pharmaceuticals, Inc. "CoolTouch" and "CoolTouch-II" Nd: YAG Laser Systems
Indications for Use:
The CoolTouch Nd:YAG Laser Systems are indicated for use in Dermatological and Plastic Surgery applications including use in the treatment of fine lines and wrinkles.
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
210(K) N Prescription Use 1 Over-the-Counter Use (per 21 CFR 801.109)