(90 days)
Not Found
No
The device description focuses on a mechanical cooling system and does not mention any AI or ML components or functions.
No
The device is described as a skin-cooling device intended to minimize pain and thermal injury and provide temporary topical anesthetic relief, which are supportive functions during medical procedures rather than directly treating a disease or medical condition.
No
The DermaChiller 4 is described as a skin-cooling device used to reduce pain and thermal injury, and provide temporary anesthetic relief. Its function is therapeutic/supportive (cooling), not diagnostic (identifying or characterizing a medical condition).
No
The device description clearly outlines hardware components (refrigerant source, solenoid valve, sapphire window) that are integral to its function, indicating it is not software-only.
Based on the provided information, the DermaChiller 4 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a skin-cooling device for minimizing pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. This involves direct interaction with the patient's skin for therapeutic and pain management purposes.
- Device Description: The description details a system that sprays a refrigerant fluid onto a sapphire window for application to the skin. This is a physical cooling mechanism applied externally.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The DermaChiller 4 does not involve the analysis of any biological specimens.
Therefore, the DermaChiller 4 falls under the category of a therapeutic or pain management device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DermaChiller 4 is intended as a skin-cooling device used to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort.
Product codes
GEX
Device Description
The DermaChiller consists of a source of a refrigerant fluid controlled by an electronically operated solenoid delivery valve. The refrigerant fluid is sprayed in a controlled fashion onto a sapphire window, which is cooled and applied to skin.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
3. 510(k) SUMMARY
014253
MAR 2 6 2002
12/20/2001 Date Prepared:
Paradigm-Trex, LLC Submitter: 10455 Pacific Center Court San Diego, CA 92121-4339 Contact Person: Nikolai Tankovich, Ph.D. MD Phone: 858-646-5721 FAX: 858-646-5701
Device Trade Name: DermaChiller 4
Skin refrigerant Common Name:
Class II (21 CFR 878.4810) Classification: Laser surgical instrument for use in general and plastic surgery and in dermatology.
Product Code: GEX
Performance Standards:
None established (as a medical device) under Section 514.
Description of Device:
The DermaChiller consists of a source of a refrigerant fluid controlled by an electronically operated solenoid delivery valve. The refrigerant fluid is sprayed in a controlled fashion onto a sapphire window, which is cooled and applied to skin.
Intended Use of the Device:
The DermaChiller 4 is intended as a skin-cooling device used to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort.
Substantial Equivalence Claim to:
-
- CoolSpot 510(k) Number K984110
-
- Dynamic Cooling Device 510(k) Number K001589
-
- DermaCool-510(k) Number K990417
6
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 6 2002
Paradigm Trex, LLC Nikolai Tankovich, Ph.D., M.D. Chief Executive Officer 10455 Pacific Center Court San Diego, California 92121-4339
Re: K014253
Trade Name: DermaChiller 4 Regulation Number: 878.4810 Regulation Name: U or reloved instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II Product Code: GEX Dated: December 20, 2001 Received: December 26, 2001
Dear Dr. Tankovich:
We have reviewed your Section 510(k) premarket 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) 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, eond 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.
2
Page 2 - Nikolai Tankovich, Ph.D., M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin mansting your valence of your device to a legally premarket notification. The PDA mixing of basification 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 If you desire specific advice for your devices disgnostic devices), please contact the Office of additionally 21 CFK Part 807.10 for in Viato Classions on the promotion and advertising of Compliance at (301) 594-4097. Tidatonally) 18 - 4639. Also, please note the your device, prease odmate and extereference to premarket notification™ (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your responsibility of the mer 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,
Muriam C. Provost
G 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
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2. INDICATIONS FOR USE STATEMENT
K014253 510(k) Number:
DermaChiller 4 Device Name:
Indications for Use: The DermaChiller 4 is intended as a skin-cooling device to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDHR, office of Device Evaluation (ODE)
Prescription Use
✓
OR
Over-The-Counter Use_
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K014253