(63 days)
Not Found
No
The summary describes a physical cooling device with no mention of AI or ML capabilities, data processing, or performance metrics typically associated with AI/ML devices.
No
DermaCool is an accessory to a laser or light source, which are therapeutic devices. However, DermaCool itself is a cooling device intended for pain reduction and discomfort during these treatments, not to treat a disease condition directly. It functions as a supportive device rather than a primary therapeutic one.
No
The device description and intended use clearly state that DermaCool is a skin-cooling device used to reduce pain and discomfort during laser or light treatment, not to diagnose medical conditions from image processing.
No
The device description explicitly states it is a "skin-cooling device" that utilizes a "cooled sapphire window, or lens, which comes in contact with skin" to perform cooling. This indicates a physical hardware component is integral to the device's function.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- DermaCool's Function: DermaCool is a device that cools the skin externally during laser or light treatments. It does not perform any tests on samples taken from the body. Its function is purely physical – to cool the skin for pain reduction and comfort.
- Intended Use: The intended use clearly states its purpose is for cooling the skin in conjunction with laser/light treatments for dermatological lesions. This is a therapeutic/procedural support function, not a diagnostic one.
Therefore, DermaCool falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DermaCool™ is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for:
- The reduction of pain,
- Less discomfort,
- Cooling of the skin prior, during and after laser or light treatment.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
DermaCool™ is a skin-cooling device designed for lasers or light sources, which are used for skin treatment applications such as vascular lesions or hair removal. A piece of cooled sapphire window, or lens, which comes in contact with skin, performs skin cooling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Not Found
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.
0
APPENDIX VII
510(k) summary of Safety and Effectiveness
Submitter: OptoMed, Inc.
13091 Pond Springs Road Austin, TX 78729
- I. Classification: Class II
- II. Common or usual name: Accessory to laser system
- III. Proprietary Name: DermaCool™
- IV. Registration No.: 1645461
- V. Classification Name: Accessory to laser system, powered, 79GEX, CFR 878-4810, Class II.
- VI. Performance standards: None established (as a medical device) under section 514.
- DermaCool™ is a skin-cooling device designed for lasers or VII. Description: light sources, which are used for skin treatment applications such as vascular lesions or hair removal. A piece of cooled sapphire window, or lens, which comes in contact with skin, performs skin cooling.
- VIII. Labels and Labeling: Labels and Instructions for Use are provided. Competitive labels and labeling are provided and the products are compared.
- IX. Indications for Use: DermaCool™ is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for:
-
- The reduction of pain,
-
- Less discomfort,
-
- Cooling of the skin prior, during and after laser or light treatment.
-
- The DermaCoolTM is substanially equilvalent to X. Substantial Equivalence: laser accessories cleared by Candela under K974381 as a laser accessory, and under K951033 as a pack, hot or cold. It is also equivalent to Cool Laser Optics, Inc. CLO Cool Wand, Cool Bag, and CLO Recirculating Slim Pack which do not appear to have 510(k) clearance.
The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle's head is facing left, and its body is curved. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 1399
Shahriar Ghaffari, Ph.D. President OptoMed. Inc. 13091 Pond Spring Road Austin, Texas 78729
K990417 Re: Trade Name: DermaCool™ System and Handpiece Regulatory Class: II Product Code: GEX Dated: February 3, 1999 Received: February 10, 1999
Dear Dr. Ghaffari:
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.
2
Page 2 - Shahriar Ghaffari, Ph.D.
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
Page_44of_61
990417 510(k) Number (if known):__
Device Name: DermaCoo1 System and Handpieces
Indications For Use: DermaCool is intended for use with a laser or light source utilized for photo-coagulation of dermatological lesions and is a cooling device indicated for: '
-
- The reduction of pain,
-
- . Less discomfort,
-
- Cooling of the skin prior, during and after laser or light treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
tacoella
(Division Sign-Off)
Division of General Restorative Devices K990417
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)