(144 days)
Not Found
No
The summary describes a laser system with standard components and control electronics, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML development and validation.
Yes
The device is intended for the "treatment of facial wrinkles," which is a therapeutic purpose.
No
The device is described as a laser system intended for the treatment of facial wrinkles, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components, including a laser system console, handpiece, skin cooling device, and footswitch/handswitch. This indicates it is a hardware-based medical device with integrated software, not a software-only device.
Based on the provided information, the Candela GentleYAG Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of facial wrinkles." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system designed to deliver energy to the skin. There is no mention of components or processes related to analyzing biological samples.
- No mention of IVD-related activities: The document does not mention any activities typically associated with IVDs, such as sample collection, preparation, analysis of biological markers, or providing diagnostic information based on in vitro testing.
Therefore, the Candela GentleYAG Laser System is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Candela GentleYAG Laser is intended for use in the treatment of facial wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device 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
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
ELA
I. General Information
KO22951
JAN 2 7 2003
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.
| Applicant: | Candela Corporation |
|---|---|
| Address: | 530 Boston Post Road |
| Wayland, MA 01778-1886 | |
| Contact Person: | Lorraine Nelson |
| Manager, Regulatory Affairs | |
| Date Prepared: | August 27, 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 (K020021) |
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
1
022951 2/2
V. Intended Use
- The GentleYAG Laser is intended for use in the treatment of facial wrinkles. ●
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 are substantially equivalent to the currently marketed Candela Long Pulse Nd: YAG Laser System (K010104) and the Laserscope Lyra Surgical Laser System (K020021).
VII. Safety and Effectiveness Information
The new indications for use are based on the indications for use for the predicate laser svstems.
Technologically, the Candela GentleYAG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), and the Laserscope Lyra Surgical Laser System (K02002) 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 intended uses.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them. The logo is black and white.
Public Health Service
JAN 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Candela Corporation William H. McGrail Vice President, Research & Development & Operations 530 Boston Post Road Wayland, Massachusetts 01778
Re: K022951 Trade/Device Name: Gentle YAG Laser Syster 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: December 16, 2002 Received: December 17, 2002
Dear Mr. McGrail:
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 no: 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
3
Page 2 - Mr. William H. McGrail
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in 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. 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for
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 icon on the left and the word "CANDELA" on the right. The flame icon is black and white and has a modern, geometric design. The word "CANDELA" is written in a simple, sans-serif font.
INDICATION FOR USE STATEMENT
510(k) Number (if known): ヒロ2299
Device Name:
Candela Corporation Gentle Y AG Laser System
Indication For Use:
The Candela GentleYAG Laser System is intended for the treatment of facial wrinkles.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C Provost
Vision Sign-Off ivision of General, Restorative ad Neurological Devices
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_________