CANDELA GENTLE YAG LASER SYSTEM

K022923 · Candela Corp. · GEX · Mar 13, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K022923
• Device Name: CANDELA GENTLE YAG LASER SYSTEM
• Applicant: Candela Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Mar 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

GentleYAG Laser System; Nd:YAG laser console; lens-coupled optical fiber handpiece; integrated skin cooling device; footswitch/handswitch; remote interlock. Used in clinical settings by physicians for dermatological procedures. Laser energy delivered to target tissue; skin cooling device protects epidermis during treatment. Output: laser pulses for photocoagulation, hemostasis, or tissue ablation. Enables treatment of pigmented lesions, vascular scars, and hair removal. Benefits: precise tissue interaction, reduced thermal damage to surrounding skin, effective management of resistant lesions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Nd:YAG laser system; console with control electronics; lens-coupled optical fiber handpiece; integrated skin cooling device; footswitch/handswitch; remote interlock. Class II laser surgical instrument.

Indications for Use

Indicated for patients requiring treatment of benign pigmented lesions (lentigos, cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos), reduction of hypertrophic/keloid scar redness, hair removal (skin types I-VI), photocoagulation/hemostasis of pigmented/vascular lesions, and soft tissue coagulation/hemostasis.

Regulatory Classification

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.

Predicate Devices

• Candela Long Pulse Nd: Yag Laser (K010104)
• Altus Family of Cool Glide Lasers (K014040)

Submission Summary (Full Text)

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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<br>Wayland, MA 01778-1886 |
| Contact Person: | Lorraine Nelson<br>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<br>for use in General and Plastic Surgery and in<br>Dermatology) |
| III. Predicate Devices | Candela Long Pulse Nd: Yag Laser (K010104)<br>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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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<br>(Per 21 CFR 801.109) | <div style="text-align:center;">X</div> |
|------------------------------------------|-----------------------------------------|
|------------------------------------------|-----------------------------------------|

| 510(k) Number | K022423 |
|----------------------|---------|
| Over-The-Counter Use | |