SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER by GLOBAL USA DISTRIBUTION, LLC.

1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.

1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

Device Description

The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser is a compact self-contained device that delivers a beam of laser energy at infrared wavelengths of 1064 nm and 1320 nm to the treatment site. The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser consists of six (6) primary components:

Laser console;
Internal computer;
Control panel and display;
Optical delivery system;
Hand set with integrated cooling (chilled sapphire optical window);
Foot switch
The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.

AI/ML Overview

The provided text does not describe specific acceptance criteria and a study proving the device meets those criteria. Instead, it is a 510(k) summary for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving performance against predefined acceptance criteria through a clinical study.

Here's a breakdown of why this information is absent and what the document does provide:

No Clinical Performance Data: The document explicitly states "Clinical Performance Data: None" and "Nonclinical Performance Data: None." This immediately tells us that no studies were conducted to gather performance metrics against acceptance criteria for this specific device.
Substantial Equivalence: The conclusion states: "The SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser shares the same indications for use, similar design features (including wavelengths, laser medium, power supply, cooling and control systems), functional features (including power output, repetition rate, energy, spot sizes and energy fluence), and is therefore substantially equivalent to the above legally marketed laser systems currently in commercial distribution." This is the core of a 510(k) submission – demonstrating similarity to a device already on the market, avoiding the need for new clinical trials in many cases.

Therefore, for the specific questions asked, the answers are largely "Not applicable" or "None provided" based on the nature of this 510(k) submission.

Here's how to answer based on the provided document, addressing each point:

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

Acceptance Criteria	Reported Device Performance
Not applicable	Not applicable
Explanation: The document does not provide specific acceptance criteria or performance metrics for this device. Its approval is based on substantial equivalence to predicate devices, not on meeting pre-defined performance benchmarks from a study for this device.

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

Sample Size (Test Set): Not applicable, as no clinical or performance test set data specific to this device is provided.
Data Provenance: Not applicable.

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)

Number of Experts: Not applicable.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable.

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

MRMC Comparative Effectiveness Study: No, not applicable. This is a laser device, 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

Standalone Performance Study: No, not applicable. This is a physical laser device, not an algorithm.

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

Type of Ground Truth: Not applicable, as no clinical study or performance data generation for this specific device is described.

8. The sample size for the training set

Sample Size (Training Set): Not applicable, as no algorithm training or clinical study for this device is described.

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

Ground Truth Establishment for Training Set: Not applicable.

Summary based on the document:

This 510(k) submission for the SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices. No new clinical performance data, nonclinical performance data, or studies (such as those involving test sets, training sets, experts, or multi-reader studies) were submitted for this specific device. The device's approval is based on its similar design, functional features, and indications for use as compared to the listed predicate devices.

Summary

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

K080697

APR - 7 2008

510(k) Summary

AMJET Distribution, LLC SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser 510(k) Premarket Notification

Submitter:	Global USA Distribution, LLC
Address:	10723 Aquila Av. S.
Contact Person:	Ronald E. Berglund
Telephone:	952-220-3014
Facsimile:	952-888-8887
Date Prepared:	August 31, 2007
Device Trade Name:	SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser
Classification Name:	Instrument, Powered, Laser79-GEX 21 CFR 878.4810
Legally Marketed PredicateDevices:	Sciton Profile ThermaScan (K032459),CoolTouch CT3S Nd: YAG Laser System(K043046), Cutera CoolGlide CV Laser(K023954), Cynosure Acclaim DermatologyLaser (K011828), Sciton Profile Multi-PlatformSystem (K070388), Candela GentleYag(K033172)

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

Description of the Long-Pulse Nd: Y AG Laser:

1. Laser console;
1. Internal computer;

Control panel and display;
Optical delivery system;
Hand set with integrated cooling (chilled sapphire optical window);
Foot switch

The SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser is not battery operated, but is controlled and operated with the aid of computer software.

Intended Use of the Long-Pulse Nd: Y AG Laser:

1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts. scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Café au lait macules, seborrheic keratoses, nevi. chloasma, verrucea, skin tags, keratoses, and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long-term, or permanent, hair reduction through selective targeting of merlanin in hair follicles, and for the treatment of pseudofolliculitis

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

	barbae. Indicated for use on all skin types(Fitzpatrick I-IV), including tanned skin.
	1320 nm: For use in dermatology for incision,excision, ablation and vaporization with hemostasisof soft tissue. For use in the treatment of fine linesand wrinkles. It is also indicated for the treatment ofback acne and atrophic acne scars.
Nonclinical PerformanceData:	None
Clinical PerformanceData:	None
Additional Information	None requested at this time
Conclusion:	The SKIN CLEAR SRVH Long Pulsed Nd:YAGLaser shares the same indications for use, similardesign features (including wavelengths, lasermedium, power supply, cooling and controlsystems), functional features (including poweroutput, repetition rate, energy, spot sizes and energyfluence), and is therefore substantially equivalent tothe above legally marketed laser systems currentlyin commercial distribution.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the left side of the image. The text is in all capital letters.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 7 2008

Global USA Distribution, LLC % Underwriters Laboratories, Inc. Mr. Ned Devine Sr. Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062

Re: K080697

Trade/Device Name: SKIN CLEAR SRVH Long Pulsed Nd: YAG Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 31, 2008 Received: April 1, 2008

Dear Mr. Devine:

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

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

Page 2 – Mr. Ned Devine

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mullison

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): _ KO80697

Device Name: SKIN CLEAR SRVH Long Pulsed Nd:YAG Laser

Indications for Use:

Prescription Use: X AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (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)

Neat R.P. Oyler for mkm
sion Sign Off

Division Sign-Off) Division of General. Restorative, and Neurological Devices

510(k) Number_KO80697

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.