(71 days)
Palomar E2000 System, Laserscope Coolspot, Optimed Dermacool, Candela Dynamic cooling device.
Not Found
No
The description focuses on a physical cooling mechanism (Peltier element, metallic finger) and temperature control based on a sensor, with no mention of AI/ML algorithms for decision-making, image processing, or data analysis.
No
The device is a cooling device intended to reduce pain and discomfort associated with laser treatment and cool the skin, which falls under supportive or adjunctive functions rather than direct therapeutic intervention to treat a disease, injury, or condition.
No
The device is described as a skin-cooling device used to reduce pain and discomfort during laser treatment, not to diagnose any condition. Its function is therapeutic/supportive, not diagnostic.
No
The device description explicitly states it consists of a control device, a treatment applicator, hose lines, a Peltier element, a metallic finger transfer medium, and a temperature sensor. These are all hardware components.
Based on the provided information, the TECHNOSANAT KRYO TSK 2005 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "surface cooling during cutaneous laser treatment" and is indicated for "reduction of pain," "less discomfort," and "cooling of the skin." These are all related to physical treatment and comfort during a medical procedure, not the diagnosis of a disease or condition using samples from the human body.
- Device Description: The description details a device that generates cold via a Peltier element and applies it directly to the skin via a metallic finger. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information.
Therefore, the TECHNOSANAT KRYO TSK 2005 is a therapeutic or procedural support device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TECHNOSANAT KRYO TSK 2005 is intended for use in conjunction with a laser to provide surface cooling during cutaneous laser treatment and is a cooling device indicated for:
-
The reduction of pain associated with laser treatment,
-
Less discomfort.
-
Cooling of the skin just before laser impulse treatment.
Refer to the user manual for the laser to which the device is attached for cleared indications for use.
Product codes
GEX
Device Description
TECHNOSANAT KRYO TSK 2005 is a skin-cooling device designed for support of laser treatment. The device consists of a control device and the treatment applicator which are connected via hose lines. Cold is generated in the applicator by means of Peltierelement, and directed to the patient via a metallic finger transfer medium. A piece of cooled metal comes in contact with skin and performs skin cooling. The treatment temperature is recorded by means of one temperature sensor in the applicator and is then displayed on the device's temporatur controllar
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)
None. The specifications and intended uses of TECHNOSANT KRYO TSK 2005 are the same or very similar to those of claimed predicate devices. Because of this, performance data were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Palomar E2000 System, Laserscope Coolspot, Optimed Dermacool, Candela Dynamic cooling device.
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
Image /page/0/Picture/1 description: The image shows a black circle with a white rectangle in the middle. The word "TECHNOSANAT" is written in black capital letters inside the white rectangle. The background of the image is white.
TECHNOSANAT Innovative Medizintechnik Joerg Trempert, Gewerbepark Keplerstrasse 10 -12, 07549 Gera, Germany
510(k) SUMMARY
TECHNOSANAT KRYO TSK 2005
This 510(k) summary of safety and effectiveness for the TECHNOSANAT Innovative Medizintechnik TECHNOSANAT KRYO TSK 2005 is submitted in accordance with the requirements of 21 CFR Part 807 Subpart E § 807.92 and follows the DSMA Office of Health and Industry Programs Guidance: Premarket Notification 510(k) - Regulatory Requirements for Medical Devices (HHS Publication FDA 95-4158, August 1995) concerning the requirements for a 510(k) Summary and Statement.
| Applicant: | TECHNOSANAT
Innovative Medizintechnik |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Gewerbepark Keplerstrasse 10 -12
07549 Gera, Germany |
| Contact Person: | Joerg Trempert
President |
| Phone:
Fax:
e-mail: | +49 365 7349 280
+49 365 7349 289
technosanat@tgz.gera.de |
| Preparation date: | July 10, 1999 |
| Device name: | Cooling device TECHNOSANAT KRYO TSK 2005 |
| Common Name: | TECHNOSANAT KRYO TSK 2005 |
| Classification
Name: | Cooling device as accasessory to a Laser surgical instrument for use
in general and plastic surgery and in dermatology (21 CFR 878.4810)
Product code: GEX - Laser instrument, surgical, powered
Panel: SU |
| Legally marketed
devices (SE): | The Technosanat Kryo TSK 2005 is substantially equivalent to the Palomar
E2000 System, Laserscope Coolspot, Optimed Dermacool an the Candela
Dynamic cooling device. The operating principle of these devices is topical
application of a low-temperature material to the surface of the skin in order to
reduce its temperature. |
| | See also Table of Comparison. |
| Device Description: | TECHNOSANAT KRYO TSK 2005 is a skin-cooling device designed for
support of laser treatment. The device consists of a control device and the
treatment applicator which are connected via hose lines. Cold is generated in
the applicator by means of Peltierelement, and directed to the patient via a
metallic finger transfer medium. A piece of cooled metal comes in contact with
skin and performs skin cooling. The treatment temperature is recorded by
means of one temperature sensor in the applicator and is then displayed on
the device's temporatur controllar |
1
| Intended Use: | TECHNOSANT KRYO TSK 2005 is intended for use in conjunction with a
laser to provide surface cooling during cutaneous laser treatment and is a
cooling device indicated for:
- The reduction of pain associated with laser treatment,
- Less discomfort,
- Cooling of the skin just before the laser impulse treatment. |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to: | The intended use of the TECHNOSANT KRYO TSK 2005 is substantially
equivalent to predicate devices in that they are intended to reduce pain and
minimize thermal injury to skin structures during laser therapy. |
| Performance data: | None. The specifications and intended uses of TECHNOSANT KRYO TSK
2005 are the same or very similar to those of claimed predicate devices.
Because of this, performance data were not required. |
| CONCLUSION: | The risks and benefits for the TECHNOSANT KRYO TSK 2005 are
comparable to the predicate devices when used for similar clinical applications
and therefore is the TECHNOSANT KRYO TSK 2005 substantially equivalent
to legally marketed devices. |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 OCT
Technosant Innovative Medizintechnik, GMBH C/o Mr. William Kelley Aesculap-Meditec North America 2525 McGaw Avenue Irvine, California 92623
Re: K992536
Trade Name: TECHNOSANAT KRYO TSK 2005 Regulatory Class: II Product Code: GEX Dated: July 7, 1999 Received: July 29, 1999
Dear Mr. Kelley:
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 Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
3
Page 2 - Mr. William Kelley
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
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K992536
Device Name: TECHNOSANAT KRYO TSK 2005
Indications For Use:
TECHNOSANAT KRYO TSK 2005 is intended for use in conjunction with a laser to provide surface cooling during cutaneous laser treatment and is a cooling device indicated for:
-
The reduction of pain associated with laser treatment,
-
Less discomfort.
-
Cooling of the skin just before laser impulse treatment.
Refer to the user manual for the laser to which the device is attached for cleared indications for use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K992536
510(k) Number