(122 days)
(K)110502, (K)110304, (K)100893
Not Found
No
The summary describes a multi-laser system with different handpieces for various dermatological and aesthetic treatments. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML capabilities in the device description, intended use, or performance studies.
Yes
The device is intended for various medical and aesthetic treatments, including skin ablation, treatment of wrinkles, soft tissue cutting, tattoo removal, treatment of vascular and pigmented lesions, and hair removal, all of which are therapeutic applications.
No
The provided text describes the device's indications for use, which involve therapeutic treatments like skin ablation, tattoo removal, hair removal, and treatment of various lesions, not diagnosis. There is no mention of the device being used to identify or characterize medical conditions.
No
The device description explicitly states it consists of a console and four separate handpieces (Er:YAG laser, Nd:YAG laser, Diode laser, and IPL handpiece), which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The description clearly states the device is a laser system with various handpieces designed for direct treatment of the skin (ablation, dermabrasion, tattoo removal, hair removal, treatment of lesions, etc.). These are all procedures performed on the patient's body, not on specimens taken from the body.
- Intended Use: The intended uses listed are all therapeutic or aesthetic procedures performed directly on the patient.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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)
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin, facial and leg veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TriPlex Laser System (K)110502, Apex Laser System (K)110304, Cheveux Laser System (K)100893
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
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 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.
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
None
Results of Clinical Study:
Technical Specifications Comparison:
2
Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System
ﮯ ،
Nd:YAG Handpiece Specification
Page 3 of 4
| | UltraLight LLC Multi-Laser System | Sandstone Medical Technologies
LLC 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-Laser
System | Sandstone Medical
Technologies LLC
Cheveux (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-Laser
System | Sandstone Medical
Technologies 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-Laser
System | Sandstone Medical
Technologies 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 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 ●
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
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