(190 days)
No
The document describes a laser system with standard components and does not mention any AI or ML capabilities in its description, intended use, or performance studies.
Yes.
The device is used to treat various medical conditions such as benign pigmented lesions, reduction of red pigmentation in scars, and photocoagulation and hemostasis of lesions, which are therapeutic applications.
No
The device description and intended use indicate the device performs therapeutic actions (e.g., removal, reduction, coagulation) rather than diagnostic functions (e.g., identifying disease, assessing condition).
No
The device description explicitly lists multiple hardware components, including a laser system console, handpiece, cooling device, and switches, indicating it is a hardware-based medical device with integrated software.
Based on the provided information, the Candela GentleYAG Laser is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The intended uses listed for the GentleYAG Laser are all related to treating conditions directly on the patient's body (skin lesions, hair removal, scar reduction, etc.).
- The device description focuses on the laser system and its components for delivering energy to the body. There is no mention of handling or analyzing biological samples.
The GentleYAG Laser is a therapeutic device that uses laser energy to treat various skin and tissue conditions.
N/A
Intended Use / Indications for Use
The Candela GentleYAG Laser is intended for use for:
- Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar . lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue black tattoos) and plaques.
- Pigmented lesions to reduce lesion size, for patients with lesions that would . potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is . an integral part of the scar.
Product codes
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)
Reference Device(s)
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.
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Image /page/0/Picture/1 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 sans-serif font.
KO22923
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: | August 22, 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) |
| Altus Family of Cool Glide Lasers (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. Intended Use
The GentleY AG Laser is intended for use in the treatment of :
- . Benigm pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue black tattoos) and plaques.
- Pigmented lesions to reduce lesion size, for patients with lesions that would . potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- Reduction of red pigmentation in hypertrophic and keloid scars where . vascularity is an integral part of the scar.
- Removal of unwanted hair in skin types I to VI .
- Photocoagulation and hemostasis of pigmented and vascular lesions .
- . Coagulation and hemostasis of soft tissue.
VI. Rationale for Substantial Equivalence
The Candela GentleYag 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 Altus Family of Cool Glide Lasers (K014040).
VII. Safety and Effectiveness Information
The new indications for use are based on the indications for use for the predicate laser systems.
Technologically, the Candela GentleYAG Laser is identical to the previous predicate Candela Long Pulse Nd: YAG Laser (K010104), therefore the risks and benefits for the GentleYAG Laser are comparable to this predicate device.
We therefore believe that there are no new questions of safety or effectiveness raised by the introduction of the device.
VIII. Conclusion
Candela believes that the GentleYAG 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.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 3 2003
Candela Corporation Lorraine Nelson Manager. Regulatory Affairs 530 Boston Post Road Wayland, Massachusetts 01778-1886
Re: K022923
Trade/Device Name: Gentle YAG 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 3, 2002 Received: September 4, 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 the
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Page 2 -- Ms. Lorraine Nelson
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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for
Celia M. Witten, Ph.D., MD
Celia M. Witten, Ph.D., MD 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 sans-serif font.
INDICATION FOR USE STATEMENT
K-022923 510(k) Number (if known):
Device Name:
Candela Corporation GentleY AG Laser System
Indications For Use:
The Candela GentleYAG Laser is intended for use for:
- Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar . lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue black tattoos) and plaques.
- Pigmented lesions to reduce lesion size, for patients with lesions that would . potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
- Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is . an integral part of the scar.
(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
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | ----------------------------------------- |
| 510(k) Number | K022423 |
|---|---|
| Over-The-Counter Use |