SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM
Device Facts
| Record ID | K140009 |
|---|---|
| Device Name | SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM |
| Applicant | Alma Lasers , Ltd. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Aug 29, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano XLi and Soprano ICE] is intended for use in dermatologic and general surgical procedures.
Device Story
Multi-application laser platform; utilizes diode laser and near-infrared (NIR) modules for dermatologic and surgical procedures. Diode modules (810nm, 755nm) deliver energy for hair removal and lesion treatment; NIR modules emit infrared energy for topical heating. Operated by clinicians in clinical settings via main console and footswitch. Features include contact thermo-electric cooling and in-motion treatment modes. System provides audible/visual exposure indicators. Clinicians use device output to perform hair reduction and therapeutic heating; benefits include permanent hair reduction and temporary pain relief.
Clinical Evidence
Bench testing only. No clinical data presented. Safety and effectiveness supported by performance testing, including electrical safety (IEC 60601-1, IEC 60601-2-22), electromagnetic compatibility (IEC 60601-1-2), and laser safety (IEC 60825-1). Software verified and validated per IEC 62304 and ISO 14971. Optional tapered light guide verified per ISO 13485 and 21 CFR 820.
Technological Characteristics
Multi-application platform using diode laser (810nm, 755nm) and NIR (1300nm) modules. Features contact thermo-electric cooling, 12-inch LCD touch screen interface, and audible/visual exposure indicators. Energy delivery via pulsed mode. Non-sterile, cleanable. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, and IEC 60825-1.
Indications for Use
Indicated for permanent hair reduction (long-term, stable reduction in hair regrowth at 6, 9, and 12 months) and treatment of benign vascular and pigmented lesions on all skin types (Fitzpatrick I-VI), including tanned skin. NIR modules indicated for topical heating to elevate tissue temperature for temporary relief of minor muscle/joint pain and stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation, and relaxation of muscles (may help muscle spasms, minor sprains, and minor muscular back pain).
Regulatory Classification
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.
Predicate Devices
- Alma Lasers Modified Diode Laser Module with SHR Treatment Mode (K112031)
- Modified Alma Lasers Family of Soprano Family XL Multi Application Platform (K102716)
- Alma Lasers Soprano XL Multi-Application Platform (K083848)
- Alma Lasers NIR Module (K080318)
- Alma Lasers Alex755 Module (K090571)
- Sciton Clear Scan (K101916)
- Quanta System Ultrawave III EX 1320 (K083207)
Related Devices
- K102716 — MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS · Alma Lasers, Inc. · Sep 28, 2010
- K201594 — Primelase Excellence · High Technology Products S.L.U · Dec 17, 2020
- K172193 — Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules · Alma Lasers, Inc. · Jan 9, 2018
- K230308 — Alma Harmony · Alma Lasers, Inc. · Mar 1, 2023
- K141237 — HARMONY LITE · Alma, Inc. · Mar 13, 2015
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2014
Alma Lasers Ltd % Kathy Maynor Consultant 26 Rebecca Court Homosassa, Florida 34446
Re: K140009 Trade/Device Name: The Modified Alma Lasers XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano 31 Soprano 10 and Soprano 105] 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, ILY Dated: April 26, 2014 Received: June 3, 2014
Dear Ms. Maynor:
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
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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 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/Resourcesfor You/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.
for
Sincerely yours,
# David Krause -S
- 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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| 510(k) Number (if known): | K140009 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | The Modified Alma Lasers Soprano XLTM Family of Multi-Application and Multi-<br>Technology Platforms [Soprano XL, Soprano XLi and Soprano ICE] |
# Intended Use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano de, Soprano de and Soprano (5) is intended for use in dermatologic and general surgical procedures.
## Indications for Use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano ^', Soprano * and Soprano "CE] includes Diode Laser and NIR Modules
Diode Laser Modules:
The indications for use for the 810mm Modified Diode Laser Module 1.2 cm² include:
- The Hair Removal (HR) and Super Hair Removal(SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch (LB) Mode)
. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR. SHR and LB Modes)
Optional Tapered Light Guide: It is intended for the same use as the device.
The indications for use for the 810nm Modified Diode Laser Module 2 cm² include:
- . The Hair Removal (HR) and Super Hair Removal(SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
The indications for use for the 755nm Diode Laser Module include:
- The Hair Removal (HR) and Super Hair Removal(SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode) 트
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes) .
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### NIR Modules
The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating. The indications for use for NIR Modules are :
- Elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, 트
- The temporary relief of minor joint pain associated with arthritis,
- 프 The temporary increase in local circulation where applied, and
- 미 The relaxation of muscles; may also help muscle spasms, minor sprains and minor muscular back pain.
| Prescription Use | <span style="font-size: 16px;">✓</span> | 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)
For BSA
Neil R Ogden -S
2014.08.28 14:45:04 -04'00'
| Page | 1 of 1 |
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### Section 8 – 510(k) Summary or 510(k) Statement
#### I. General Information
| Submitter: | Alma Lasers, Ltd,<br>Halamish St. POB 302<br>Industrial Park, 38900 |
|---------------------------|---------------------------------------------------------------------|
| Contact Person: | Kathy Maynor<br>Consultant<br>352-586-3113 (cell) |
| Summary Preparation Date: | Aug 28, 2014 |
#### II. Names
| Device Names: | The Modified Alma Lasers Soprano XL™ Family of Multi-<br>Application and Multi-Technology Platforms [Soprano XL,<br>Soprano XLi and Soprano ICE] |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Classification Names: | Surgical Powered Light Instrument,<br>Lamp, Infrared, Therapeutic Heating |
#### III. Predicate Devices
| K | # | Predicate Device |
|---------|---|-----------------------------------------------------------------------------------------------------------------------------------------|
| K112031 | | Alma Lasers Modified Diode Laser Module with SHR Treatment<br>Mode for use with the family of Soprano XL Multi-Application<br>Platforms |
| K102716 | | Modified Alma Lasers Family of Soprano Family XLTM Multi<br>Application Platform (SopranoXL, SopranoXLi). |
| K083848 | | Alma Lasers Soprano XL Multi-Application Platform |
| K080318 | | Alma Lasers NIR Module |
| K090571 | | Alma Lasers Alex755 Module |
| K101916 | | Sciton Clear Scan |
| K083207 | | Quanta System Ultrawave III EX 1320 |
#### IV. Product Description
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano ™ and Soprano "CE] is a modification to previously cleared Soprano Family XL ™M
Multi Application Platform [Soprano **] The relevant K number is K102716
Soprano 40, the new addition to the family has hand pieces with multiple wavelengths, spot sizes and supports both Diode Laser and Near Infrared (NIR) Technologies. The Soprano 40 comprises of the following major components:
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- 1. The main console unit
- 2. Footswitch.
- 3.
#### V. Indications for Use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology
Platforms [Soprano ** and Soprano *** and Soprano *** jis intended for use in dermatolog
The Indications for Use are provided in Section 7 of this submission.
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#### VI. Summary of Technical Characteristics
### Table 1: Salient Characteristics of the modified diode 810nm module spot size 1.2 cm2 and the Predicate Devices
| | K14<br>Alma Lasers Modified 810nm Diode<br>Laser Module to be used with cleared<br>Soprano XL and XLi Platform and<br>proposed SopranoICE | K112031<br>Alma Lasers Modified Diode Laser Module with<br>SHR Treatment Mode used with the Soprano XL<br>Multi-application Platforms | K102716<br>Modified Alma Lasers Family of<br>Soprano Multi-Application Platforms<br>[Soprano XLTM, Soprano XLiTM] | K083848<br>Alma Lasers Soprano<br>XL Multi-Application<br>Platform | Parameter | K13<br>Alma Lasers Modified 810nm Diode Laser Module<br>to be used with cleared Soprano XL and XLi<br>Platform and proposed Soprano ICE | K112031<br>Alma Lasers Modified Diode Laser Module with SHR Treatment Mode<br>used with the Soprano XL Multi-application Platforms | K102716<br>Modified Alma Lasers Family of Soprano Multi-<br>Application Platforms [Soprano XLTM, Soprano<br>XLITM] | K083848<br>Alma Lasers Soprano XL Multi-<br>Application Platform |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Parameter<br>Product Code &<br>Regulation No. | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | Product Code &<br>Regulation No. | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 | GEX<br>21 CFR 878.4810 |
| Diode Module<br>Modes | *SHR *HR *LB | SHR HR LB | HR LB | HR | Diode Module Modes | SHR<br>HR | SHR HR LB | HR LB | HR |
| Laser Wavelength<br>[nm] | 810(nominal) | 810(nominal) | 810(nominal) | 810(nominal) | Laser Wavelength [nm] | 810(nominal) | 810(nominal) | 810(nominal) | 810(nominal) |
| Light/Laser<br>Source | Diode | Diode | Diode | Diode | Light/Laser Source | Diode | Diode | Diode | Diode |
| Spot<br>Size[mm*mm] or<br>[cm2] | 12*10 or 1.2, optional 6mm round<br>tapered light guide tip | 12*10 or 1.2 | 12*10 or 1.2 | 12* 10 or 1.2 | Spot Size[mm*mm] or<br>[cm2] | 20*10 or 2 | 12*10 or 1.2 | 12*10 or 1.2 | 12* 10 or 1.2 |
| Fluence<br>(Energy Density)<br>[J/cm2] | 2-20 | 2-120 Up to 40 | $≤$ 10 $≤$ 120 | $≤$ 80 $≤$ 120 | Fluence<br>(Energy Density)<br>[J/cm2] | Up to 20 | <=10 <=120 <=80 | <=120 <=80 | <=120 |
| Rep Rate [Hz] | 5-10 | 0.5-3 2 | $≤$ 3 | $≤$ 3 | Rep Rate [Hz] | 5-10 | <=10 <3 | <3 | <3 |
| Pulse Duration<br>[ms] | 3.3-200 | $≤$ 20 | 5-200 | 5-200 | Pulse Duration [ms] | 3.3-200 | <=20 5-200 | 5-200 | 5-200 |
| Tissue Cooling | Contact continuous, thermo-electrical | Contact continuous, thermo-electrical | Contact continuous, thermo-electrical | Contact continuous,<br>thermo-electrical | Tissue Cooling | Contact continuous, thermo-electrical | Contact continuous, thermo-electrical | Contact continuous, thermo-electrical | Contact continuous, thermo-electrical |
| How Supplied | Non-sterile, cleanable | Non-sterile, cleanable | Non-sterile, cleanable | Non-sterile, cleanable | How Supplied | Non-sterile, cleanable | Non-sterile, cleanable | Non-sterile, cleanable | Non-sterile, cleanable |
| Exposure<br>Indicator | Audible & visual indicator | Audible & visual indicator | Audible & visual indicator | Audible & visual<br>indicator | Exposure Indicator | Audible & visual indicator | Audible & visual indicator | Audible & visual indicator | Audible & visual indicator |
| Compatible Laser<br>System | Family of Soprano XL, XLi (cleared) &<br>proposed SopranoICE | Family of Soprano XL and XLi Multi<br>Application | Family of Soprano XL and XLi Multi<br>Application Platforms | Soprano XL System | Compatible Laser<br>System | Family of Soprano XL, XLi (cleared) & Soprano Ice | Family of Soprano XL and XLi Multi Application | Family of Soprano XL and XLi Multi Application<br>Platforms | Soprano XL System |
| Dimensions<br>[inches] | 6.69*4.8*1.9 | 6.75*5.75*2.5 | 6.75*5.75*2.5 | 6.75*5.75*2.5 | Dimensions ["] | 6.69*4.8*1.9 | 6.75*5.75*2.5 | 6.75*5.75*2.5 | 6.75*5.75*2.5 |
| User Interface | 12" LCD touch screen | 12" LCD touch screen | 8" LCD touch screen | 8" LCD touch screen | User Interface | 12" LCD touch screen | 12" LCD touch screen | 8" LCD touch screen | 8" LCD touch screen |
| Indications for<br>Use | Permanent reduction in<br>hair regrowth * | Treatment of<br>benign vascular and<br>pigmented lesions | Hair Removal, Permanent<br>hair reduction Treatment of<br>benign vascular and<br>pigmented lesions | Hair Removal,<br>Permanent hair<br>reduction | Indications for Use | Permanent reduction in hair<br>regrowth* | Hair Removal, Permanent hair reduction | Hair Removal,<br>Permanent hair reduction | Hair Removal, Permanent<br>hair reduction |
| Indicated for use on all Skin Types (Fitzpatrick Skin Types I-VI), including tanned skin * SHR-Super Hair Removal, HR-Hair Removal, LB-Laser Blanche | | | | | | Treatment of benign<br>vascular and<br>pigmented lesions | Treatment of benign<br>vascular and<br>pigmented lesions | Treatment of benign vascular<br>and pigmented lesions | |
| ** Permanent Reduction in hair regrowth is defined as the long -term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12<br>months after the completion of a treatment regimen. | | | | | Indicated for use on all Skin Types (Fitzpatrick Skin Types I-VI), including tanned skin | | | | |
| *Permanent Reduction in hair regwoth is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after th | | | | | | | | | |
| completion of a treatment regimen | | | | | | | | | |
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Table 2: Salient Characteristics of the modified diode 810nm module spot size 2 cm2 and the Predicate Devices
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### Table 3-1: Salient Characteristics of 755nm diode module and the predicate devices
| | K13<br>Alma Lasers 755nm Diode Module | | | K090571<br>Alma Lasers ALEX755 Module | | K083207<br>Quantum Ultrawave III | |
|-------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------|------------------------|------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Parameter | | | GEX | | GEX | | |
| Product Code<br>& Regulation No. | GEX<br>21 CFR 878.4810 | | | 21 CFR 878.4810 | | 21 CFR 878.4810 | |
| Intended Use | HR and SHR<br>Permanent<br>reduction in<br>hair regrowth* | LB Mode: Treatment of benign<br>vascular and pigmented lesions | | HR and SHR Mode :Hair<br>removal and permanent<br>hair reduction | Treatment of benign vascular<br>and pigmented lesions | Intended for coagulation and hemostatis of vascular lesions and the removal and<br>permanent reduction of unwanted hair in Fitzpatrick skin types I-VI, including<br>suntanned skin types. Also indicated for pigmented<br>Lesions and wrinkles. | |
| Indicated for | all Skin Types (Fitzpatrick skin types I-VI), including<br>tanned skin | | | | all skin types (Fitzpatrick skin types I-VI), including tanned skin | | |
| Wavelength [nm] | 755 | | 755 | | 755 | | |
| Light/Laser<br>Source | Diode | | Long Pulse Alexandrite | | Long Pulse Alexandrite | | |
| Beam Delivery | Direct | | Direct | | Direct | | |
| Pulse Width<br>[msec] | 3.3-200 | | | 3 - 100 | | 3-100 | |
| Pulse Repetition<br>Rate [Hz] | SHR:<br>5-10 | HR:<br>0.5-3 | LB<br>2 | 2, 4 | | upto 1.5 | |
| Spot Size cm2 | 1.5 | | 5mm round( . 79cm2) | 10mm(3.14cm2) | upto 16mm | | |
| Energy Density<br>(Fluence) [J/cm2] | 2-20<br>2-120<br>Up to 25 | | 32 | 8 | up to 123J/cm2 | | |
Permanent Reduction in hair regwoth is defined as the reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the
completion of a treatment regimen
*
・ .
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### Table 3-2: Salient Characteristics of 755nm diode module and the predicate device
| | K13<br>Alma Lasers 755nm Diode Mo dule | | K090571<br>Alma Lasers ALEX755 Module | | K101916<br>Sciton | |
|-------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Parameter | | | | | | |
| Product Code<br>& Regulation No. | GEX<br>21 CFR 878.4810 | | GEX<br>21 CFR 878.4810 | | GEX<br>21 CFR 878.4810 | |
| Intended Use | HR and SHR Mode | LB Mode: Treatment of benign vascular and pigmented lesions<br>Permanent reduction in hair regrowth * | HR and SHR Mode :Hair removal and permanent hair reduction | Treatment of benign vascular and pigmented lesions | The Clearscan ALX 755nm alexandrite laser system with its accessories is indicated<br>for stable long term or permanent hair reduction for all skin types (Fitzpatrick I-VI)<br>including tanned skin. It is also indicated for the treatment of vascular lesions, benign<br>Pigmented lesions and wrinkles | |
| Indicated for | all Skin Types (Fitzpatrick skin types I-VI), including tanned skin | | | | all skin types (Fitzpatrick skin types I-VI), including tanned skin | |
| Wavelength [nm] | 755 | | 755 | | 755 | |
| Light/Laser<br>Source | Diode | | Long Pulse Alexandrite | | Long Pulse Alexandrite | |
| Beam Delivery | Direct | | Direct | | Direct | |
| Pulse Width<br>[msec] | 3.3-200 | | 3 - 100 | | Up to 200msec | |
| Pulse Repetition<br>Rate [Hz] | SHR:<br>5-10 | HR:<br>0.5-3<br>LB<br>2 | 2, 4 | | unk | |
| Spot Size cm2 | 1.5 | | 5mm round(.79cm2)<br>10mm(3.14cm2) | | 3mm, 6mm single spot, up to 30mm x 30mm scanned area | |
| Energy Density<br>(Fluence) [J/cm2] | 2-20 | 2-120<br>Up to 25 | 32<br>8 | | Up to 140j/cm² | |
Permanent Reduction in hair regrowth is defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the
completion of a treatment regimen
*
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Table 4: Salient Characteristics of Alma Lasers NIR Large Module and the predicate devices
| | K13<br>Alma Lasers NIR LargeModule | K080318<br>Alma Lasers NIR Module | K050370<br>Palomar LuxIR Hand piece | K042165<br>Cutera Titan Tabletop Product<br>K033768 - Altus Medical<br>Optional Infrared Handpiece* |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | | | | |
| Product Code & | ILY | ILY | ILY | ILY |
| Regulation No. | 21CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 | 21 CFR 890.5500 |
| Wavelength [nm] | 1300 | 800-1,800 | 800-1,800 (Cleared)<br>850-1350 (marketing material) | 850-3,000<br>(filtered 1,100-1,800) |
| Lamp Type | Quartz Tube | Quartz tube | Quartz tube | Quartz tube |
| Intended Use | Intended to emit energy in the infrared<br>spectrum to provide topical heating for<br>the purpose of elevating the tissue<br>temperature | Intended to emit energy in the infrared<br>spectrum to provide topical heating for the<br>purpose of elevating the tissue temperature | Intended to emit energy in the infrared<br>spectrum to provide topical heating for<br>the purpose of elevating the tissue<br>temperature | Intended to emit energy in the<br>infrared spectrum to provide<br>topical heating for the purpose of<br>elevating the tissue temperature |
| Indications for<br>Use | For the temporary relief of minor muscle<br>pain and joint pain and stiffness, the<br>temporary relief of minor joint pain<br>associated with arthritis, the temporary<br>increase in local circulation where<br>applied, and the relaxation of muscles;<br>may also help muscle spasms, minor<br>sprains and strains, and minor muscular<br>back pain. | For the temporary relief of minor muscle<br>pain and joint pain and stiffness, the<br>temporary relief of minor joint pain<br>associated with arthritis, the temporary<br>increase in local circulation where applied,<br>and the relaxation of muscles; may also<br>help muscle spasms, minor sprains and<br>strains, and minor muscular back pain. | For the temporary relief of minor muscle<br>pain and joint pain and stiffness, the<br>temporary relief of minor joint pain<br>associated with arthritis, the temporary<br>increase in local circulation where<br>applied, and the relaxation of muscles;<br>may also help muscle spasms, minor<br>sprains and strains, and minor muscular<br>back pain. | For the temporary relief of minor<br>muscle pain and joint pain and<br>stiffness, the temporary relief of<br>minor joint pain associated with<br>arthritis, the temporary increase in<br>local circulation where applied,<br>and the relaxation of muscles; may<br>also help muscle spasms, minor<br>sprains and strains, and minor<br>muscular back pain. |
| Power Control | Time control | Time control | Time control | Exposure time |
| Mode | Pulsed | Pulsed | Pulsed | Pulsed |
| Fluence [J/cm2] | 0.55-5.5 | 5.5 | Up to 100 | 5 - 65 |
| Pulse Width [sec] | 1-5 | 1 - 5 | 2.5 - 5 | Not available |
| Spot Size<br>[mm*mm] or cm2] | 18 | 60 x 30 | 12 x 28 | 10 x 15; 10 x 30 |
| Cooling | Contact cooling<br>Thermo-electric (TEC) | Contact cooling<br>Thermo-electric (TEC) | Contact Cooling | Temperature regulated contact<br>cooling |
| Treatment Mode | In-motion | In-motion | Stationary | Stationary |
| Exposure<br>Indicator | Audible & visual indicator | Audible & visual indicator | Not available | Audible tone and LED indicator |
| How Supplied | Non-sterile, cleanable | Non-sterile, cleanable | Non-sterile, cleanable | Non-sterile, cleanable |
| Module<br>Dimensions | 190*80*56mm (L*W*H)…
