(211 days)
Not Found
Not Found
No
The description focuses on the laser technology and its physical characteristics, with no mention of AI or ML.
Yes
The device is described as treating various medical conditions and performing medical procedures such as incision, excision, ablation, and vaporization of soft tissue, indicating its use for therapeutic purposes.
No
The Intended Use/Indications for Use section states that the device is intended for the treatment of various lesions and for the incision, excision, ablation, vaporization of soft tissue. It describes therapeutic applications, not diagnostic ones.
No
The device description clearly describes a physical laser system with specific dimensions, weight, and electrical requirements, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the treatment of various conditions (vascular lesions, pigmented lesions, hair, tattoos) and for the incision, excision, ablation, vaporization of soft tissue. These are all therapeutic or surgical procedures performed on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system used for delivering energy to tissue, not for analyzing biological samples.
The function of this device is to directly interact with and modify tissue, which is characteristic of a therapeutic or surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Affinity QS laser is intended for treatment of vascular lesions, pigmented lesions, and for hair, tattoo removal, and the incision, excision, ablation, vaporization of soft tissue for general dermatology.
Product codes
GEX
Device Description
The Affinity QS Q-Switched Nd:YAG Laser is a Q-Switched, frequency doubled laser system. It provides both 1064nm and 532nm wavelengths. Laser emission activation is by foot switch. Overall weight of the laser is 180 lbs., and the size is 25" x 15" x 78" (LxWxH). Electrical requirement is 230 VAC, 20A, 50-60 Hz, single phase.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Performance Data: none
Clinical Performance Data: none
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medlite C6 Q-Switched Nd:YAG Laser system
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
510(K) : ummary
SEP 1 4 2005
| Submitter: | Cynosure, Inc.
10 Elizabeth Drive
Chelmsford, MA 01824 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | George Cho
Senior Vice President of Medical Technology |
| Date Summary Prepared: | February 14, 2005 |
| Device Trade Name: | Affinity QS Q-Switched Nd:YAG Laser system |
| Common Name: | Q-Switched Nd:YAG laser |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.48 |
| Equivalent Device: | Medlite C6 Q-Switched Nd:YAG Laser system |
| Device Description: | The Affinity QS Q-Switched Nd:YAG Laser is a Q-Switched,
frequency doubled laser system. It provides both 1064nm and 532nm
wavelengths.
Laser emission activation is by foot switch. Overall weight of the laser
is 180 lbs., and the size is 25" x 15" x 78" (LxWxH).
Electrical requirement is 230 VAC, 20A, 50-60 Hz, single phase. |
| Intended Use: | The Affinity QS laser is intended for treatment of vascular lesions,
pigmented lesions, and for hair, tattoo removal, and the incision,
excision, ablation, vaporization of soft tissue for general dermatology. |
| Comparison: | The Affinity QS laser system has identical indication for use, the same
principle of operation, and essentially the same wavelength range and
pulse energy range as the predicate device. |
| Nonclinical Performance Data: | none |
| Clinical Performance Data: | none |
| Conclusion: | The Affinity QS laser is a safe and effective device for the treatment of
vascular and pigmented lesions, for hair and tattoo removal, and for
the incision, excision, ablation, vaporization of soft tissue for general
dermatology. |
| Additional Information: | none |
:
:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.
Public Health Service
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. George Cho Senior Vice President Medical Technoogy Cynosure Incorporated 10 Elizabeth Drive Chelmsford, Massachusetts 01824
Re: K050382 Trade/Device Name: Cynosure Affinity QS Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: August 31, 2005 Received: September 2, 2005
Dear Mr.Cho:
We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 9 rotty premained is substantially equivalent (for the indications referenced above and nave determined the actived predicate devices marketed in interstate for use stated in the encrosule for legally manatise to of the Medical Device American of Grod. Ford, Drug commerce prior to May 28, 1776, the enacting with the provisions of the Federal Food. Drug. devices that have been reclassified in acceraanse while has remarket approval application (PMA). and Cosment Act (Act) that to not require approvide controls provisions of the Act. The You may, therefore, market the device, belyer to the more
general controls provisions of the Act include requirements for annual registration, listing of general controls provisions of the Hecking, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) me existing major regulations affecting your device can may be subject to such additional controlls. Extrangemand on 898. In addition, FDA may be found in the Code of Peachar Regerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I Dri- 3 issuation or our device complies with other requirements of the Act that TDA has made a decorminations administered by other Federal agencies. You must of ally Federal statures and regulations adminited to: registration and listing (21 comply with an the Act 81equire Rart 801); good manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2- Mr. George Cho
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your article quivalence of your device to a legally
premarket notification. The FDA finding of substantial end thus, permits vo premarket notification. The FDA Inding of substantial equice 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), please
rs the latest of the many of the 1076 0115 . Algeralation entitled If you desire specific advice for your de not on on S. Also, please note the regulation entitled, the may obtain contact the Office of Compliance at (240) 270 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by relerence to premarket notifiedavin (e. the Act from the Division of Small other general information on your responsion.com at its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at the Admanain html Manufacturers, International and Consulter Piersons. Passions of thinksma/dsmamain.html
Sincerely yours,
Aubrey Buchus
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name: _Cynosure Affinity QS Laser
Indications For Use:
The Affinity QS Laser is intended for the treat nent of vasular lesions, and for The Affinity QS Laser is intended for the treat of vascular resoluly plantined and of the for general dermatology.
OR Prescriptive Use_ x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINF - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, ( vffice of Device Evaluation (ODE)
Barbara Buell for MM
(Division Sign-O Division of General, Re and Neurological Devices
510(k) Number L050382
Image /page/3/Picture/12 description: The image shows the words "Prescription Use" with a line underneath the words. There is a check mark to the right of the words. The words are written in a simple, sans-serif font. The image is simple and straightforward.
Over-The-Counter Use_______
(Optional Format 1-2-96)