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, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

The Nd:YAG handpiece is indicated for:

At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair.
At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)

The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for:

Hair Removal
Permanent hair reduction
Treatment of vascular lesions
Treatment of benign pigmented lesions
Treatment of Leg Veins
Treatment for pseudofolliculitis barbae

The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:

Hair Removal (650nm filter)
Permanent hair reduction (650nm filter)
Treatment of vascular lesions (510nm filter)
Treatment of benign pigmented lesions (510 nm filter)
Mild to Moderate inflammatory acne (450nm filter)

Device Description

The MultiLaser System consists of a console that houses the power supply, control electronics and user interface and four separate handpiece. The four handpieces consist of an Er:YAG laser handpiece, an Nd:YAG laser handpiece, a Diode laser handpiece and an IPL handpiece.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the MultiLaser System, focusing on acceptance criteria and the supporting study information:

Acceptance Criteria and Device Performance Study

The provided document (510(k) summary) explicitly states "Performance Data: None" and "Results of Clinical Study: None". This indicates that no specific acceptance criteria based on performance outcomes or clinical study results are presented, nor is there a study detailing the device's performance against such criteria.

Instead, the submission for the MultiLaser System relies on substantial equivalence to legally marketed predicate devices. The acceptance criteria, in this context, are met by demonstrating that the MultiLaser System's technical specifications and intended uses are sufficiently similar to those of the predicate devices. The "study" proving this is a technical specifications comparison rather than a performance or clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

As no performance data or clinical study results are provided, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in technical specifications to predicate devices. The "reported device performance" in this context refers to the device's technical specifications matching or being within the acceptable range of the predicate devices.

Specification Category	Acceptance Criteria (Predicate Device)	Reported Device Performance (MultiLaser System)
Nd:YAG Handpiece
Energy	Up to 1000mJ (TriPlex K110502)	Up to 1000mJ
Maximum Fluence	12J/cm² (TriPlex K110502)	12J/cm²
Wavelength	1064nm and 532nm (TriPlex K110502)	1064nm and 532nm
Spot Size	up to 5mm (TriPlex K110502)	up to 5mm
Pulse Width	10ns (TriPlex K110502)	10ns
Pulsewidth (Variable)	Single pulse and variable 0.06 sec - continuous (TriPlex K110502)	Single pulse and variable 0.06 sec - continuous
Repetition Rate	1-5Hz (TriPlex K110502)	1-5Hz
Aiming Beam	HeNe (TriPlex K110502)	HeNe
Diode Laser Handpiece
Light Source	Diode Array (Cheveux K100893)	Diode Array
Wavelength	810nm (Cheveux K100893)	810nm
Energy Density	Up to 100J/cm² (Cheveux K100893)	Up to 100J/cm²
Spot Size	14x 10 mm (Cheveux K100893)	14x 10 mm
Pulse Width	Up to 400ms (Cheveux K100893)	Up to 400ms
Beam Delivery System	Light Guide (Cheveux K100893)	Light Guide
Er:YAG Laser Handpiece
Wavelength	2940nm (TriPlex K110502)	2940nm
Max Power	2.4 W (TriPlex K110502)	2.4 W
Max Fluence	8 J/cm² (TriPlex K110502)	8 J/cm²
Pulse Width	300 μs (TriPlex K110502)	300 μs
Repetition Rate	Up to 10 pulse per second (TriPlex K110502)	Up to 10 pulse per second
Spot Size	1.5mm, 3mm, 6mm, 9mm (TriPlex K110502)	1.5mm, 3mm, 6mm, 9mm
IPL Handpiece
Light Source	Pulsed Incoherent Light (Apex K110304)	Pulsed Incoherent Light
Max Fluence	Up to 35J/cm² (Apex K110304)	Up to 35J/cm²
Wavelength	450 - 1200 nm (Apex K110304)	450 - 1200 nm
Spot Size	35 x 15 mm² (Apex K110304)	35 x 15 mm²
Pulse Width	Up to 200ms (Apex K110304)	Up to 200ms
Beam Delivery System	Light Guide (Apex K110304)	Light Guide

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. No test set involving patient data or performance metrics was used for this 510(k) submission. The "test" was a comparison of technical specifications.
Data Provenance: Not applicable.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. Ground truth from experts in a clinical or performance setting was not established for this submission. The "ground truth" was the technical specifications of the predicate devices.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no clinical or performance 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

MRMC Study: No. The device is a laser system, not an AI-assisted diagnostic tool.

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

Standalone Performance: No. The device is a laser system, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the substantial equivalence determination was the published technical specifications and intended uses of previously cleared predicate devices.

8. The Sample Size for the Training Set

Sample Size: Not applicable. There was no training set, as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable.

Summary

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Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System

ﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ

ﻴﺔ

This 510(K) Summary of safety and effectiveness for the MultiLaser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary. UltraLight Laser Technologies, LLC Applicant: UltraLight Laser Technologies LLC 105 Citation Court

Contact Person:

Telephone: Fax: Email:

K123777

Address:

Preparation Date:

Device Trade Name:

Common Name:

Classification Name:

Classification

Legally Marketed Predicate Device(s):

Description of the MultiLaser System:

Intended use of the MultiLaser System

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, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

The Nd:YAG handpiece is indicated for:

At the 1064 nm wavelength dark ink tattoo . removal, removal of pigmented lesions and the removal or lightening of hair.
At the 532 nm wavelength removal of red ink . tattoos, treatment of vascular lesions including facial
ર- I

Page 1 of 4

Mr. Mark Rohrer

1-205-356-1172 1-205-356-1171 ssmed@bellsouth.net

Birmingham, AL 35209

November 30, 2012

MultiLaser System

Laser

Instrument, Surgical, Powered, laser GEX, 21 CFR 878.4810

Powered light based non-laser surgical instrument with thermal effect ONF, 21 CFR 878.4810

TriPlex Laser System (K)110502 Apex Laser System (K)110304 Cheveux Laser System (K)100893

Class II

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

Attachment 5

510(K) Summary as required by section 807.92(c).

MultiLaser System

Page 2 of 4

and leq veins. telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)

The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for:

. Hair Removal
- . Permanent hair reduction
- Treatment of vascular lesions .
- . Treatment of benign pigmented lesions
- . Treatment of Leg Veins
. Treatment for pseudofolliculitis barbae

The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale following . for the indications:

Hair Removal .
- (650nm filter)
Permanent hair reduction . (650nm filter)
. Treatment of vascular lesions (510nm filter)
. Treatment of benign pigmented lesions (510 nm filter)
. Mild to Moderate inflammatory acne (450nm filter)

Performance Data:

None

Results of Clinical Study:

Technical Specifications Comparison:

K123777

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

Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System

K123777

ﮯ ،

Nd:YAG Handpiece Specification

Page 3 of 4

	UltraLight LLC Multi-Laser System	Sandstone Medical TechnologiesLLC TriPlex (K110502)
Energy	Up to 1000mJ	Up to 1000mJ
Maximum Fluence	12J/cm2	12J/cm2
Wavelength	1064nm and 532nm	1064nm and 532nm
Spot Size	up to 5mm	up to 5mm
Pulse Width	10ns	10ns
Pulsewidth	Single pulse and variable . 0.06 sec- continuous	Single pulse and variable . 0.06 sec- continuous
Repetition Rate	1-5Hz	1-5Hz
Aiming Beam	HeNe	HeNe

Diode Laser Handpiece Specification

	UltraLight LLC Multi-LaserSystem	Sandstone MedicalTechnologies LLCCheveux (K100893)
Light Source	Diode Array	Diode Array
Wavelength	810nm	810nm
Energy Density	Up to 100J/cm²	Up to 100J/cm²
Spot Size	14x 10 mm	14x 10 mm
Pulse Width	Up to 400ms	Up to 400ms
Beam Delivery System	Light Guide	Light Guide

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

Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System

K123777

Page 4 of 4

Er:YAG Laser Handpiece Specification

	UltraLight LLC Multi-LaserSystem	Sandstone MedicalTechnologies LLC TriPlex(K110502)
Wavelength	2940nm	2940nm
Max Power	2.4 W	2.4 W
Max Fluence	8 J/cm2	8 J/cm2
Pulse Width	300 μs	300 μs
Repetition Rate	Up to 10 pulse per second	Up to 10 pulse per second
Spot Size	1.5mm, 3mm, 6mm, 9mm	1.5mm, 3mm, 6mm, 9mm

Intense Pulsed Light (IPL) Handpiece Specification

	UltraLight LLC Multi-LaserSystem	Sandstone MedicalTechnologies LLC Apex(K110304)
Light Source	Pulsed Incoherent Light	Pulsed Incoherent Light
Max Fluence	Up to 35J/cm²	Up to 35J/cm²
Wavelength	450 - 1200 nm	450 - 1200 nm
Spot Size	35 x 15 mm²	35 x 15 mm²
Pulse Width	Up to 200ms	Up to 200ms
Beam Delivery Stem	Light Guide	Light Guide

Conclusion:

The MultiLaser System is substantially equivalent to other existing laser and IPL systems in commercial distribution for use in Dermatology and Plastic Surgery.

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

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

UltraLight Laser Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Birmingham, Alabama 35209

April 11, 2013

Re: K123777

Trade/Device Name: MultiLaser 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: February 21, 2013 Received: March 11, 2013

Dear Mr. Rohrer:

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

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

Page 2 – Mr. Mark Rohrer

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/CDRH/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/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

PeterD.Rumm-S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K123777

Multi-Laser Laser System Device Name:

The Nd:YAG handpiece is indicated for:

At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented . lesions and the removal or lightening of hair.
At the 532 nm wavelength removal of red ink tattoos, treatment of vascular . lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)

The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for:

Hair Removal .
Permanent hair reduction ●
Treatment of vascular lesions .
· · Treatment of benign pigmented lesions
. Treatment of Leg Veins
Treatment for pseudofolliculitis barbae ●

Neil R Ogdens // 0 10 11:21 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123777

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

The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:

Hair Removal .
Permanent hair reduction .
. Treatment of vascular lesions
Treatment of benign pigmented lesions .
Mild to Moderate inflammatory acne .

(650nm filter) (650nm filter) (510nm filter) (510 nm filter) (450nm filter)

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogder 2013.04.10 10:14:45 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123777

Page 2 of 2

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.