(26 days)
Not Found
No
The summary describes a laser device for tattoo and lesion removal, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML development or performance evaluation.
Yes
The device is indicated for the removal of tattoos and benign cutaneous pigmented lesions, which constitutes a medical treatment.
No
Explanation: The device is indicated for tattoo and benign cutaneous pigmented lesion removal, which are therapeutic procedures, not diagnostic.
No
The device description clearly states it consists of hardware components: power supply, water cooling system, and optical bench.
Based on the provided information, the Cynosure Accolade Laser is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "tattoo and benign cutaneous pigmented lesions removal." This describes a therapeutic or cosmetic procedure performed directly on the patient's skin (in vivo).
- Device Description: The description details a laser system with a power supply, cooling system, and optical bench. This is consistent with a device that delivers energy to tissue, not a device that analyzes samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are designed to diagnose diseases or conditions based on in vitro testing.
Therefore, the Cynosure Accolade Laser is a therapeutic/cosmetic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cynosure Accolade Laser is indicated for tattoo and benign cutaneous pigmented lesions removal.
Product codes
GEX
Device Description
The Accolade Laser consists of three interconnected sections: the power supply, the water cooling system and the optical bench.
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
Nonclinical Performance Data: None
Clinical Performance Data: None
Key Metrics
Not Found
Predicate Device(s)
Cynosure PhotoGenica HT10 Laser
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
SEP 1 5 1500
长992814
510(K) Summary
| Submitter: | Cynosure, Inc.
10 Elizabeth drive
Chelmsford, MA 01824 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | August 18, 1999 |
| Device Trade name: | Cynosure Accolade Laser |
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device | Cynosure PhotoGenica HT10 Laser |
| Device description: | The Accolade Laser consists of three
interconnected sections: the power supply, the
water cooling system and the optical bench. |
| Intended Use: | Tattoo and benign cutaneous pigmented lesions
removal. |
| Comparison: | The Accolade Laser is substantially equivalent to
the Cynosure PhotoGenica HT10 Laser in terms
of treatment wavelength, pulse duration, pulse
energy, and biological effects. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Cynosure Accolade Laser is another safe and
effective laser for tattoo and benign cutaneous
pigmented lesions removal. |
| Additional Information: | None requested at this time. |
1
Image /page/1/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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1999
Mr. George Cho Senior Vice President Cynosure, Inc. 10 Elizabeth Drive Chelmsford. Massachusetts 01824
Re: K992814 Trade Name: Cynosure Accolade Laser Regulatory Class: II Product Code: GEX Dated: August 18, 1999 Received: August 20, 1999
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 requirement, as set forth in the Quality 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.
2
Page 2 - Mr. George Cho
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_ of
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Cynosure Accolade Laser
Indications For Use:
The Cynosure Accolade Laser is indicated for tattoo and benign cutaneous pigmented lesions removal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
A. Coley
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K992814