(89 days)
Not Found
Not Found
No
The summary describes a cooling tip for a laser, with no mention of AI, ML, image processing, or data analysis that would suggest AI/ML is incorporated.
No
The device is indicated for cooling the skin during dermatology laser treatment, which is a supportive function rather than a direct therapeutic intervention.
No
The provided text describes a device used for cooling the skin during laser treatments, which is a therapeutic or procedural function, not a diagnostic one. Diagnostic devices are used to identify or detect a disease or condition.
No
The 510(k) summary describes a "Laser Cooling Tip," which is a physical component used with a laser. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to cool the skin during dermatology laser treatment procedures. This is a direct interaction with the patient's body during a medical procedure, not an examination of specimens in vitro (outside the body).
- Device Description: While the description is "Not Found," the intended use clearly points to a device used on the patient's skin.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on laboratory analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely procedural support during a treatment.
N/A
Intended Use / Indications for Use
The Cynosure Dermatology Laser Cooling Tip is indicated for cooling the skin during dermatology laser treatment procedures.
Product codes
GEX
Device Description
Not Found
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)
Not Found
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Senior Vice President, Medical Technology Cynosure, Inc. 35 Wiggins Avenue Bedford, Massachusetts 01730-2314
AUG 27 1997
Re: K972002 Trade Name: CYNOSURE Dermatology Laser Cooling Tip Regulatory Class: II Product Code: GEX Dated: May 29, 1997 Received: May 30, 1997
Dear Mr. Cho:
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 requirements , as set forth in the Quality System Regulation (OS) 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. Fallure 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.
1
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,
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
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Page 1 of 1
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications fer Use: ---------------------------------------------------------------------------------------------------------------------------------------------------------
The Cynosure Dermatology Laser Cooling Tip is indicated for cooling the skin during dermatology laser treatment procedures.
(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
| 510(k) Number | K972002 |
|---|---|
| --------------- | --------- |
| Prescription Use
| (Per 21 CFR 801.109) | ✓ | OR | Over-the-Counter Use |
|---|---|---|---|
| ------------------------------------------ | -------------- | ---- | ---------------------- |
(Optional Format 1-2-96)