(27 days)
No
The summary describes a mechanical handpiece with a variable spot size and a coolant sensor. There is no mention of AI, ML, image processing, or any data-driven decision-making capabilities.
Yes
The device is an accessory to a laser system (CoolTouch "Varia" Nd:YAG Laser System) that is cleared for therapeutic indications such as hair removal and soft tissue hemostasis of vascular lesions.
No
The device is an accessory to a laser system used for hair removal, tissue hemostasis, and treating pigmented lesions. These are therapeutic applications, not diagnostic ones.
No
The device description clearly states it is a "fiber optic handpiece," which is a hardware component used with a laser system. It describes physical features like spot size adjustment and a coolant sensor.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The CoolTouch VariZoom Variable Spot Size Reusable Fiber Optic Handpiece is an accessory for a laser system used for procedures performed on the body (hair removal, soft tissue hemostasis, pigmented lesion treatment). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes procedures performed directly on the patient's skin and tissues.
Therefore, this device falls under the category of a medical device used for therapeutic or cosmetic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CoolTouch VariZoom Variable Spot Size Reusable Fiber Optic Handpiece is indicated as an accessory for use with the CoolTouch "Varia" Nd:YAG Laser System, which has been cleared for the following indications:
Hair removal (destruction of hair follicles) in all skin types and for soft tissue Hall removal (destraction of hand hemostasis of vascular lesions. For pigmented lesions approations: 1 or or organients that would potentially benefit from aggressive to reduce resion size, for patients that have not responded to other laser treatments.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The fiber optic handpiece used with the CoolTouch Varia laser system has had a fixed spot size. The user selects a 4mm, 6mm, or 8mm spot size, depending on the application. The VariZoom handpiece combines the various spot size handpieces into one, allowing the user to dial the desired spot size instead of changing handpieces. The VariZoom handpiece has the same coolant capability and incorporates a sensor to alert the user that the coolant is depleted.
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:
Conclusion:
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.
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
012982 1/2
Premarket Notification 510(k) Summary OCT - 2 2001 CoolTouch "VariZoom" Variable Spot Size Reusable Fiber Optic Handpiece
This 510(K) Summary of safety and effectiveness for the CoolTouch "VariZoom" variable spot size a reusable fiber optic handpiece is submitted in accordance with the requirements of 21 CFR 807.92.
| Applicant: | CoolTouch Corporation |
|---|---|
| Address: | 9085 Foothills Boulevard |
| Roseville, CA 95747 | |
| Contact Person: | Donald V. Johnson |
| Telephone: | (916) 677-1900 |
| Fax: | (916) 677-1901 |
| Preparation Date: | September 4, 2001 |
| Device Trade Name: | CoolTouch "VariZoom" |
| Common Name: | Laser Fiber Optic Delivery System Handpiece |
| Classification Name: | Accessory to Laser Surgical Instruments |
| 79-GEX | |
| Legally Marketed Predicate | |
| Device: | The predicate device is the CoolTouch Corporation Model |
| CoolTouch "Varia" Nd:YAG Laser System, 510(k) # K983984, | |
| July 7, 1999. The beam delivery system was described in the | |
| 510(k); the cooling handpiece was also described in detail as an | |
| accessory in the Operator Manual. | |
| Description of the | |
| CoolTouch Corporation | |
| VariZoom handpiece: | The fiber optic handpiece used with the CoolTouch Varia laser |
| system has had a fixed spot size. The user selects a 4mm, | |
| 6mm, or 8mm spot size, depending on the application. The | |
| VariZoom handpiece combines the various spot size handpieces | |
| into one, allowing the user to dial the desired spot size instead of | |
| changing handpieces. The VariZoom handpiece has the same | |
| coolant capability and incorporates a sensor to alert the user that | |
| the coolant is depleted. |
1
0129/2
The following table describes the CoolTouch "Varia" fixed spot size handpieces and compares them to the CoolTouch "VariZoom" variable spot size handpiece.
| Specification | CoolTouch "Varia"
Fixed Spot Size
Fiber Optic Handpiece | CoolTouch "VariZoom"
Variable Spot Size
Fiber Optic Handpiece |
|-----------------|----------------------------------------------------------------------|---------------------------------------------------------------------|
| Wavelength | 1064 nm | Same |
| Dimensions | 20cm x 5cm x 10cm (LxDxH) | Same |
| Weight | 2 lbs. | Same |
| Cooling | Dynamic cooling using a solenoid
valve and self-contained coolant | Same |
| Compatibility | CoolTouch Varia Nd:YAG Laser
System | Same |
| Laser Spot Size | 4, 6, 8mm | Variable, 3mm to 10mm |
| Indications | Numerous | Same |
| 510k Number | K983984
K003781
K010316 | Pending |
Technical Specification Comparison
Intended use of the CootTouch Corporation VariZoom handpiece:
The intended use of the VariZoom handpiece is the same intended use as previously cleared for the CoolTouch "Varia" Nd:YAG Laser System per 510(k) #K010316.
Nonclinical Performance Data:
None.
Clinical Performance Data:
Conclusion:
None.
The CoolTouch VariZoom handpiece described in this submission is substantially equivalent to the predicate CoolTouch 4, 6, and 8mm spot size handpieces.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing-like shapes. The eagle is positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2001
Mr. Donald V. Johnson Vice President of Operations New Star Lasers, Inc. 9085 Foothills Boulevard Roseville, California 95747
Re: K012982 Trade/Device Name: CoolTouch VariZoom Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: September 5, 2001 Received: September 5, 2001
Dear Mr. Johnson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 too based on 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 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) 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 21 CFR Part 809.10 for in vitro diagnostic devices), 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 yours,
Susa Walker, MD
fa
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Device Name
CoolTouch VariZoom Variable Spot Size Reusable Fiber Optic Handpiece
The CoolTouch VariZoom Variable Spot Size Reusable Fiber Indications for Optic Handpiece is indicated as an accessory for use with the Use CoolTouch "Varia" Nd:YAG Laser System, which has been cleared for the following indications:
Hair removal (destruction of hair follicles) in all skin types and for soft tissue Hall removal (destraction of hand hemostasis of vascular lesions. For pigmented lesions approations: 1 or or organients that would potentially benefit from aggressive to reduce resion size, for patients that have not responded to other laser treatments.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
510(k) Number -
Over-the-Counter Use
12
KO12982
(Division Sign-Off) (Division Signi-Olf)
Division of General, Restorative
Division of General, Devices Division of Gical Devices
Confidential