The GentleLASE Family of Laser Systems is indicated for temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. On all skin types (Fitzpatrick I- VI) including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

Device Description

The Candela GentleLASE Family of Laser Systems contains an alexandrite laser head, which produces laser energy emitted at nominal wavelength of 755 nm. The output of the energy is then delivered to the skin through an optical fiber delivery system which also cools the surface of the skin through either air or cryogen cooling. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat. The Dynamic Cooling Device (DCD) protects the upper layers of the skin with a cooling burst of cryogen. The GentleLase Pro and GentleLase Pro LE laser systems both have the same technological and performance specifications, the same indications for use, the same principles of operation, and the same energy type. The only difference between these two systems is the color of the side panels.

AI/ML Overview

The provided text describes the acceptance criteria and a study for the Candela GentleLASE Family of Laser Systems, but it is a 510(k) summary for a software update for an already cleared device, not an initial clearance document. Therefore, the information typically found in an initial clearance study (like detailed performance data from a clinical trial demonstrating efficacy against a specific acceptance criterion for a medical condition) is not present.

The focus of this document is on demonstrating that a software update to an existing device (GentleLASE Pro and GentleLASE Pro LE Laser Systems) does not negatively impact its safety or effectiveness compared to its predicate device (GentleMAX Family of Laser Systems, K133283).

Here's an analysis based on the provided text, highlighting what is available and what is explicitly stated as not required or not applicable in this context.

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific acceptance criteria in the way one might expect for a primary efficacy study (e.g., "X% reduction in hair"). Instead, the "acceptance criteria" here are implicitly tied to the device performing "according to specifications and functions as intended" after the software update, and maintaining substantial equivalence to the predicate device.

Acceptance Criteria (Implicit for Software Update)	Reported Device Performance (after Software Update)
Device performs according to specifications.	Performance testing demonstrated that the GentleLase Pro and GentleLase Pro LE laser systems perform according to specifications.
Device functions as intended.	Performance testing demonstrated that the GentleLase Pro and GentleLase Pro LE laser systems function as intended.
Does not affect indications for use.	The modifications made to the GentleLASE Family of Laser Systems do not affect the indications for use.
Does not alter fundamental scientific technology.	The modifications made to the GentleLASE Family of Laser Systems do not alter the fundamental scientific technology of the device.
Does not affect the mode of use.	The modifications made to the GentleLASE Family of Laser Systems do not affect the mode of use.
No new issues of safety or effectiveness are raised.	The modifications made to the GentleLASE Family of Laser Systems raises no new issues of safety or effectiveness.
Maintains similar intended uses, operating principles, design aspects (spot size, wavelength, max delivered fluence) as the predicate device.	The modified GentleLASE Family of Laser Systems have the same intended uses, utilizes similar operating principles, and matches key design aspects, including similar spot size, similar wavelength and the same maximum delivered fluence as the predicate device.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable/not provided. The study mentioned is "software verification and validation" and "performance testing" to standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22). This typically involves engineering and functional testing of the device itself, rather than testing on a "test set" of patients or cases.
Data Provenance: Not applicable, as this was not a clinical study on human subjects or patient data. It was technical testing of the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as there was no clinical "test set" requiring ground truth establishment by experts for medical conditions. The testing was technical verification and validation of the device's functional performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there was no clinical "test set" requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a laser system, not an AI diagnostic tool, and this submission is for a software update, not a new device clearance or an AI assistance study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a laser system which operates with human involvement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This is not applicable. For engineering performance testing, the "ground truth" would be the device's design specifications and the requirements of the relevant IEC standards.

8. The sample size for the training set

This is not applicable as this is a software update for a laser system, not an AI/machine learning model that typically undergoes "training."

9. How the ground truth for the training set was established

This is not applicable for the reasons mentioned in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract design of three human profiles facing right, stacked on top of each other. The profiles are rendered in a flowing, stylized manner. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 7, 2014

Candela Corporation Mr. Sam Wade Vice President, Regulatory Affairs and Quality Assurance 530 Boston Post Road Wayland, Massachusetts 01778

Re: K140732

Trade/Device Name: GentleLASE Family of Laser Systems Regulation Number: 21 CFR 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: October 9, 2014 Received: October 10, 2014

Dear Mr. Wade:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

{1}------------------------------------------------

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K140732

Device Name GentleLASE Family of Laser Systems

Indications for Use (Describe)

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias)

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

{3}------------------------------------------------

{4}------------------------------------------------

510(k) Summary GentleLASE Family of Laser Systems

General Information:

This Special 510(k) is to provide notification of a software change made for the modified GentleLASE Family of Laser Systems (GentleLase Pro and GentleLase Pro LE Laser Systems) to the previously cleared GentleMAX Family of Laser Systems (K133283) manufactured by Candela Corporation.

Submitted by:	Candela Corporation530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Sam Wade.Vice President, Regulatory Affairs and Quality AssuranceTel: 508-358-7400 x330Fax: 508-358-5602
Date prepared:	March 14, 2014
Trade Name:	GentleLASE Family of Laser Systems
Common Name:	Dermatology Laser System
Classification Name:	Laser surgical instrument for use in general and plastic surgery andin dermatology (21 CFR 878.4810, Product Code GEX)
Predicate Devices:	GentleMAX Family of Laser Systems (K133283)

Intended Use / Indications for Use:

The GentleLASE Family of Laser Systems is indicated for the following:

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

GentleLASE Family of Laser Systems

{5}------------------------------------------------

Description:

Product	Modified GentleLASE Family ofLaser Systems (GentleLase Proand GentleLase Pro LE LaserSystems)	GentleMAX Family of LaserSystems
510(k)	KXXXXXXX	K133283
Manufacturer	Candela Corporation	Candela Corporation
Product Code	GEX	GEX
RegulationNumber	21 CFR 878.4810	21 CFR 878.4810
Device Class	II	II
Indications forUse	The GentleLASE Family of LaserSystems is indicated for temporaryhair reduction. Stable long-term orpermanent reduction throughselective targeting of melanin in hairfollicles. Permanent hair reductionis defined as long-term stablereduction in the number of hairsregrowing after a treatment regime.On all skin types (Fitzpatrick I- VI)including tanned skin. Permanenthair reduction is defined as the long-term, stable reduction in the numberof hairs regrowing when measured at6, 9, and 12 months after thecompletion of a treatment regime.Treatment of benign pigmentedlesions.Treatment of wrinkles.The photocoagulation of	755nmThe GentleMAX Family of LaserSystems is indicated for temporaryhair reduction. Stable long-term orpermanent reduction throughselective targeting of melanin in hairfollicles. Permanent hair reductionis defined as long-term stablereduction in the number of hairsregrowing after a treatment regime.On all skin types (Fitzpatrick I- VI)including tanned skin. Permanenthair reduction is defined as the long-term, stable reduction in the numberof hairs regrowing when measured at6, 9, and 12 months after thecompletion of a treatment regime.Treatment of benign pigmentedlesions.Treatment of wrinkles.The photocoagulation of
Product	Modified GentleLASE Family of	GentleMAX Family of Laser
	Laser Systems (GentleLase Pro	Systems
	and GentleLase Pro LE Laser
	Systems)
	dermatological vascular lesions	dermatological vascular lesions
	(such as port-wine stains,	(such as port-wine stains,
	hemangiomas, telangiectasias).	hemangiomas, telangiectasias.

		1064nm
		The GentleMAX Family of Laser
		Systems is indicated for the removal
		of unwanted hair, for stable long
		term or permanent hair reduction
		and for treatment of PFB.
		Permanent hair reduction is defined
		as the long-term, stable reduction in
		the number of hairs regrowing when
		measured at 6, 9, and 12 months
		after the completion of a treatment
		regime. The lasers are indicated on
		all skin types Fitzpatrick I-VI
		including tanned skin.
		Photocoagulation and hemostasis of
		pigmented and vascular lesions such
		as but not limited to port wine stains,
		hemangioma, warts, telangiectasia,
		rosacea, venus lake, leg veins and
		spider veins. Coagulation and
		hemostasis of soft tissue. Benign
		pigmented lesions such as, but not
		limited to, lentigos (age spots), solar
		lentigos (sun spots), café au lait
		macules, seborrheic keratosis, nevi,
		chloasma, verrucae, skin tags,
		keratosis, tattoos (significant
		reduction in the intensity of black
		and/or blue-black tattoos) and
		plaques.The laser is indicated for 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.
		The laser is also indicated for the

Product	Modified GentleLASE Family ofLaser Systems (GentleLase Proand GentleLase Pro LE LaserSystems)	GentleMAX Family of LaserSystems
		reduction of red pigmentation inhypertrophic and keloid scars wherevascularity is an integral part of thescar.Treatment of wrinkles.
Laser type	Flashlamp-excited, Solid stateAlexandrite laser	Flashlamp-excited, Solid stateAlexandrite and Nd:YAG laser
Wavelength	755nm	755nm/1064nm
Pulse duration	3 – 300 ms	0.25 - 100 ms
Maximumfluence	$53 J/cm²$	$53 J/cm²$ (ALEX)$80 J/cm²$ (YAG)
Spot size	6, 8, 10, 12, 15, 18, 20, 22, 24mm	1.5, 3, 6, 8, 10, 12, 15, 18mm
Pulse repetitionrate	2 Hz, maximum	10 Hz, maximum
Pulsing control	Fingerswitch or footswitch	Fingerswitch or footswitch
Laser CoolingMethod	Self-contained internally circulatedliquid to air	Self-contained internally circulatedliquid to air
Productdimensions(HxWxL)	42" x 18" x 27"	42" x 18" x 27"
ProductWeight	250 lbs	260 lbs

Technological Characteristics:

{6}------------------------------------------------

{7}------------------------------------------------

Performance Data:

A software update is being made to the modified GentleLASE Family of Laser Systems (GentleLase Pro and GentleLase Pro LE) due to a recall, therefore software verification and validation have been performed. Testing to the third edition of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22 has been conducted on the GentleLase Pro and GentleLase Pro LE laser systems. All performance testing demonstrated that the GentleLase Pro and GentleLase Pro LE laser systems perform according to specifications and functions as intended.

Clinical Data:

No clinical data was required for these modifications.

Summary of Substantial Equivalence:

The modifications made to the GentleLASE Family of Laser Systems do not affect the indications for use or alter the fundamental scientific technology of the device, nor does it affect the mode of use. There are no labeling changes that affect the indications for use of the device. The modifications made to the GentleLASE Family of Laser Systems raises no new issues of safety or effectiveness. The modified GentleLASE Family of Laser Systems have the same intended uses, utilizes similar operating principles, and matches key design aspects, including

GentleLASE Family of Laser Systems

{8}------------------------------------------------

similar spot size, similar wavelength and the same maximum delivered fluence as the predicate device. The non-clinical tests that were performed that our device is as safe, as effective, and performs as well as the predicate device. On the basis of similarities in methods of assembly, method of operation, and intended uses, as confirmed by the performance testing, Candela Corporation believes that the modified GentleLASE Family of Laser Systems is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.