The Candela GentleLASE Family of Lasers utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755 nanometers in the near infrared region. Energy from the laser is directed to the target area via optical fiber handpiece delivery system. The Dynamic Cooling Device provides a short burst of cryogen spray prior to firing the laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams with diameters of 6, 8, 10, 12, 15, 18 millimeters on the skin. The cryogen, which is housed within the laser enclosure, is delivered via a hose to a nozzle located in the handpiece. The GentleLASE Family of Laser Systems are designed with six major components:

High voltage power supply and modulator system
Optical laser head
Circulator system
Optical delivery system
Software control system
Dynamic cooling device
The Candela GentleLASE Family of Laser Systems are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

AI/ML Overview

The provided text is a 510(k) summary for the Candela GentleLASE Family of Laser Systems, seeking clearance based on substantial equivalence to predicate devices. It does not contain information about a study that establishes acceptance criteria and then proves the device meets those criteria in the way described in the prompt's request.

Instead, this document focuses on demonstrating substantial equivalence to existing, legally marketed devices, rather than establishing and meeting novel performance acceptance criteria through clinical studies designed for that purpose.

Therefore, most of the requested information cannot be extracted from the provided text. Here's a breakdown of what can be inferred or directly stated, and what information is missing:

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

Not applicable. The submission focuses on demonstrating substantial equivalence to predicate devices based on shared intended uses, operating principles, and key design aspects (spot size, wavelength, maximum delivered fluence). No specific performance metrics for novel "acceptance criteria" are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No "test set" in the context of a performance study is described. The submission relies on comparisons to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No "ground truth" establishment for a performance study is described.

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

Not applicable. No "test set" or adjudication method for a performance study is described.

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

Not applicable. The device is a laser system for dermatological use, not an AI-assisted diagnostic tool for human readers.

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

This question is not relevant as the device is a laser system, not an algorithm.

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

Not applicable. No ground truth for a performance study is described. The "ground truth" in this context is the safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

Summary of Device Acceptance/Equivalence from the Provided Text:

The acceptance of the device is based on its substantial equivalence to previously cleared predicate devices. The study, in this case, is a comparison against these predicates, highlighting similarities in design and principle.

Key Information from the Document regarding "Acceptance":

Acceptance Criteria (Implicit for 510(k) submission): The device must be "substantially equivalent" to predicate devices. This is demonstrated by showing:
- Same intended uses (photocoagulation of dermatological vascular lesions).
- Similar operating principles (Alexandrite rod, 755nm pulsed energy, optical fiber handpiece delivery, Dynamic Cooling Device).
- Matches key design aspects (similar spot size, same wavelength, same maximum delivered fluence as predicate devices).
- Conforms to relevant safety standards (Laser Performance Standard (21 CFR 1040), IEC (EN) 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-22).
Reported Device Performance (as demonstrated for equivalence):
The Candela GentleLASE Family of Laser Systems has the same intended uses, utilizes similar operating principles, and matches key design aspects (including similar spot size, the same wavelength, and the same maximum delivered fluence) as the predicate devices (GentleLASE Family of Laser Systems K024371, K024335, K024260, and previous models K994260, K981351, K974381, K972767). The device also conforms to various laser and medical electrical equipment safety standards.

The FDA's letter (K11144) ultimately states: "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... You may, therefore, market the device." This constitutes the "acceptance" based on the provided evidence of equivalence.

Summary

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K IIII44

E. GentleLASE Family of Laser Systems 510k Summary

JUL 18 2011

1 :

General Information:

This 510(k) is to provide notification of substantial equivalence for the Candela GentleLASE Family of Laser Systems, which is substantially equivalent to previously marketed devices intended for photocoagulation of dermatological vascular lesions.

Submitted by:	Candela Corporation530 Boston Post RoadWayland, MA 01778-1886
Contact Person:	Scott Blood, VP of Quality and Regulatory Affairs
Date prepared:	April 5, 2011
Classification:	Class II GEX Product Code(21 CFR § 878.4810 Laser Surgical Instrument for use inGeneral and Plastic Surgery and in Dermatology)
Common Name:	Dermatology Laser, GentleLASE Family of Laser Systems
Predicate Devices:	GentleLASE Family of Laser Systems(K024371, K024335, K024260)Candela GentleLASE GL and previous Candela GentleLASEmodels (K994260, K981351, K974381, K972767)
Description:

Description:

1. High voltage power supply and modulator system
- 1. Optical laser head
- 1. Circulator system
- 1. Optical delivery system
- S. Software control system
- 1. Dynamic cooling device

The Candela GentleLASE Family of Laser Systems are equipped with safety interlock systems to protect patients and operators. Users of the device make selections from an onboard control panel to regulate operation during treatment.

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Testing:

As laser products, the GentleLASE Family of Laser Systems conform to the Laser Performance Standard (21 CFR 1040). In addition, the GentleLASE Family of Laser Systems conform to IEC (EN) 60601-1 Medical Electrical Equipment- Gen'l Requirements for Safety, 1EC 60601-1-2 Medical Electrcal Equipment- Electromagnetic Compatibility, IEC 60601-1-4 Medical Electrical Equipment- Programmable Electrical Medical Systems, and IEC 60601-2-22 Medical Electrical Equipment- Safety of Diagnostic and Therapeutic Laser Equip.

Summary of Substantial Equivalence;

The Candela GentleLASE Family of Laser Systems have the same intended uses, utilizes similar operating principles and matches key design aspects, including similar spot size, the same wavelength and the same maximum delivered fluence as the predicate devices. On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela Corporation believes that the Candela GentleLASE Family of Laser Systems are substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized symbol that resembles a person with their arms outstretched.

Public Health Service

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

JUL 1 8 2011

Candela Corporation % Mr. Scott Blood 530 Boston Post Road Wayland, Massachusetts 01778-1886

Re: K11144

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: April 12, 2011 Received: April 22, 2011

Dear Mr. Blood:

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

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Page 2 - Mr. Scott Blood

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

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

Sincerely yours,
E. L. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 411144

Device Name: GentleLASE Family of Laser Systems

Indications for Use:

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

Prescription Use X

(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nihr Ryder for nkn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111144

Modified 7/15/2011 Candela

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.