(86 days)
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard laser system components and a clinical study demonstrating safety and effectiveness.
Yes
The device is intended for the "treatment of Pseudofolliculitis Barbae," which indicates a therapeutic purpose.
No
The device is described as a laser system intended for the treatment of Pseudofolliculitis Barbae, which indicates a therapeutic rather than diagnostic purpose.
No
The device description clearly lists multiple hardware components, including a laser system console, handpiece, skin cooling device, and switches.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of Pseudofolliculitis Barbae." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system designed for delivering energy to the skin for treatment. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing specimens, diagnostic information, or any of the typical characteristics of an IVD.
Therefore, the GentleYAG Laser System, as described, is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GentleYAG Laser is intended for the treatment of Pseudofolliculitis Barbae.
Product codes
GEX
Device Description
The GentleYAG Laser consists of the following main components:
- a laser system console (including software and control electronics)
- a control and display panel .
- a lens-coupled, user replacement optical fiber handpiece .
- a skin cooling device integrated into the handpiece
- a footswitch or handswitch .
- a remote interlock connector .
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)
A clinical study produced results that indicate the GentleY AG is safe and effective for the treatment of Psuedofolliculitis Barbae.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Candela Long Pulse Nd: Yag Laser (K010104), Lyra Surgical Laser System (K003147), Altus Medical CoolGlide Laser (K014040)
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.
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Image /page/0/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black and has horizontal lines running through it. The word "CANDELA" is also black and in a sans-serif font.
DEC 2 0 2002
亿元3193
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510/k) Summary of Safety and Effectiveness for the Candela GentleYAG Laser System is being submitted in accordance with the requirements of the SMDA 1990, 21 CFR 807.92 and follows the guidance concerning the organization and content of a 510(k) summary.
I. General Information
| Applicant: | Candela Corporation |
|---|---|
| Address: | 530 Boston Post Road |
| Wayland, MA 01778-1886 | |
| Contact Person: | Lorraine Nelson |
| Manager, Regulatory Affairs | |
| Date Prepared: | September 24, 2002 |
| II. Names | |
| Device Trade Name: | GentleYAG Laser System |
| Common Name | Dermatology Laser |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument |
| for use in General and Plastic Surgery and in | |
| Dermatology) | |
| III. Predicate Devices | Candela Long Pulse Nd: Yag Laser (K010104) |
| Lyra Surgical Laser System (K003147) | |
| Altus Medical CoolGlide Laser (K014040) |
IV. Product Description
The GentleY AG Laser consists of the following main components:
- . a laser system console (including software and control electronics)
- a control and display panel .
- a lens-coupled, user replacement optical fiber handpiece .
- . a skin cooling device integrated into the handpiece
- a footswitch or handswitch .
- a remote interlock connector .
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V. Indications for Use
The GentleY AG Laser is intended for the treatment of Pseudofolliculitis Barbae.
VI. Rationale for Substantial Equivalence
The Candela GentleY AG Laser shares the same indications for use, matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate devices, and therefore is substantially equivalent to the predicate devices.
VII. Safety and Effectiveness Information
The new indications for use are based on the indications for use for the predicate laser systems.
A clinical study produced results that indicate the GentleY AG is safe and effective for the treatment of Psuedofolliculitis Barbae.
Technologically, the Candela GentleY AG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), the Laserscope Lyra Surgical Laser System (K003147) and the Altus CoolGlide Laser (K014040), therefore the risks and benefits for the GentleY AG Laser are comparable to these predicate device (s).
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device.
VIII. Conclusion
It is the opinion of Candela Corporation that the GentleY AG Laser System is substantially equivalent to the predicate devices based on operating principles, materials, mechanism of action, design, construction, methods of assembly and for the treatment of Psuedofolliculitis Barbae.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of three overlapping lines that resemble a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Candela Corporation Lorraine Nelson Manager. Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778-1886
Re: K023193
Trade/Device Name: Gentle Y AGTM Laser System Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 24, 2002
DFC 2 0 2002
Received: September 25, 2002
Dear Ms. Nelson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, 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 (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
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Page 2 - Ms. Lorraine Nelson
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
40 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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Image /page/4/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black on the left side and has horizontal lines on the right side. The word "CANDELA" is in a simple, sans-serif font.
INDICATION FOR USE STATEMENT
510(k) Number (if known): K023193
Device Name:
Gentle Y AG Laser System
Indication For Use:
The GentleYAG Laser System is intended for the treatment of Pseudofolliculitis Barbae.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
K023193
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
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