The CO2 laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology, neurosurgery, orthopedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:

· Laser skin resurfacing.
· Treatment of furrows and wrinkles.
· Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
· Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
· Blepharoplasty.
· Site preparation for hair transplants.
· The fractional scanner is for skin resurfacing.

The Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

Device Description

The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. The Er: Y AG handpiece attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.

AI/ML Overview

The provided document is a 510(k) summary for the Cortex Laser System, which is a medical laser device. It outlines the device's indications for use, technological characteristics, and claims of substantial equivalence to predicate devices. However, this document does not contain information related to acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document explicitly states: "Performance Data: None submitted." This means that no clinical performance data was provided or reviewed for this 510(k) submission. Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving the device meets them based on the provided text.

Based on the document, I can only provide the following:

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

Acceptance Criteria: Not specified in the document.
Reported Device Performance: "Performance Data: None submitted."

2. Sample sized used for the test set and the data provenance: Not applicable, as no performance data or test sets were submitted.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no ground truth establishment for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no test set data requiring adjudication was submitted.

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 described is a surgical laser, not an AI-assisted diagnostic tool for human readers. No MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a surgical laser, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no performance data requiring ground truth was submitted or its establishment described.

8. The sample size for the training set: Not applicable, as no training set for an algorithm is mentioned.

9. How the ground truth for the training set was established: Not applicable, as no training set for an algorithm is mentioned.

In summary, the provided FDA 510(k) document for the Cortex Laser System focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than presenting clinical performance data or studies against specific acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. The profiles are simple and abstract, with a flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

July 21, 2015

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

Cynosure. Incorporated dba Ellman Ms. Alison Sathe Director of Regulatory and Clinical Affairs 400 Karin Lane Hicksville, New York 11801

Re: K150587 Trade/Device Name: Cortex Laser System 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: June 15, 2015 Received: June 17, 2015

Dear Ms. Sathe:

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 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

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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/ResourcesforYou/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.

Sincerelv vours.

Joshua

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

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Indications for Use

510(k) Number (if known) K150587

Device Name Cortex Laser System

Indications for Use (Describe)

The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:

· Laser skin resurfacing.
· Treatment of furrows and wrinkles.

· Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.

· Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
· Blepharoplasty.
· Site preparation for hair transplants.
· The fractional scanner is for skin resurfacing.

Type of Use (Select one or both, as applicable)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

This 510(K) Summary of safety and effectiveness for the Cortex Laser System is submitted in accordance with the requirements of the SMDA 1990 and FDA guidance concerning the organization and content of a 510(K) summary.

Applicant:	Cynosure, Inc. dba Ellman
Address:	Cynosure, Inc. dba Ellman400 Karin LaneHicksville, NY 11801
Contact Person:	Alison Sathe
Telephone/Email/Fax:	513-658-8960asathe@ellman.com516-267-6750
Preparation Date:	February 20, 2015
Device Trade Name:	Cortex Laser System
Common Name:	CO2 Laser, Er:YAG Laser
Classification Name:	Instrument, Surgical, Powered, laser79-GEX, 21 CFR 878.4810
Legally Marketed PredicateDevice(s):	Cortex Laser System K110897DEKA SmartXide2 Laser System K133895C02-2B3 Galaxy CO2 Laser System K133915

Device Description:

Intended Use:

The CO2 laser is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

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The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery.

Dermatology, Plastic Surgery and General Surgery procedures:

Laser skin resurfacing.
. Treatment of furrows and wrinkles.
Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation.
Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications.
Blepharoplasty. ●
. Site preparation for hair transplants.
The fractional scanner is for skin resurfacing. ●

The Er: Y AG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

Technological Characteristics:

	Cortex Laser System
Source	CO2
Wavelength	10.6 micron (10,600nm)
Power to tissue	0.5 - 40 W
Peak power	200 W
Repetition Rate	1 - 8 Hz / 240 Hz Super Pulse
Pulse Length	0.1ms to 1 s
Laser operation modes	Continuous Wave, Blend (PW), Super Pulse
Aiming beam	3mW (650nm diode) adjustable
Articulated arm	7-joint articulated arm
Cooling type	Closed loop (liquid)
User Interface	LCD Touch Screen
Power input requirements	110 - 120 VAC, 10 A, 50-60 Hz
Dimension (H x W x D)	150 x 46 x 31 cm

Performance Data: None submitted.

Substantial Equivalence:

4 The Er:YAG technical specifications of the Cortex Laser System are omitted as they remain unchanged and are not being compared to the predicate device.

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The Cortex Laser System has the same intended uses and indications, technological characteristics, principles of operation as its predicate device. There are no new issues of safety or effectiveness. Thus, the Cortex Laser System is substantially equivalent to the predicate.

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.