(239 days)
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.
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) .
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.
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:
- The main console unit
- Footswitch.
The provided document is a 510(k) premarket notification for a medical device (The Modified Alma Lasers Soprano XL Family of Multi-Application and Multi-Technology Platforms). It primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technical characteristics, and adherence to safety standards.
Crucially, this document does not contain information about acceptance criteria for device performance as typically understood for studies evaluating diagnostic or therapeutic efficacy (e.g., sensitivity, specificity, accuracy). Nor does it describe a study that proves the device meets such performance criteria by comparing it against a ground truth in a clinical setting.
Instead, the "acceptance criteria" and "study" described in this document are related to:
- Substantial Equivalence: The primary "acceptance criterion" for a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
- Safety and Performance Standards: The "studies" are tests conducted to ensure the device meets specified electrical, electromagnetic, and laser safety standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and software development and risk management standards (IEC 62304, ISO 14971).
Therefore, I cannot populate the table and additional information based on the typical understanding of "acceptance criteria" for a device's clinical performance. The document focuses on showing the device is substantially equivalent to existing devices and safe according to engineering and manufacturing standards.
However, I can extract the information relevant to these types of "acceptance criteria" and "studies" as presented:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type) | Reported Device Performance (as demonstrated for Substantial Equivalence and Safety) |
|---|---|
| Substantial Equivalence to Predicate Devices | The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano XLi and Soprano ICE] shares the same or similar design features, and functional features with, and thus is substantially equivalent to, the predicate devices: K112031, K102716, K083848, K080318, K090571, K101916, K083207. Details are provided in Tables 1-5 comparing technical characteristics and indications for use. |
| Electrical Safety and Essential Performance | Tested and found compliant with IEC 60601-1: 1988+A1:1991+A2:1995: Medical Electrical Equipment Part 1: General Requirements for basic safety and essential performance. |
| Electromagnetic Compatibility (EMC) | Tested and found compliant with IEC 60601-1-2: 2001 + A1(4): Medical electrical equipment: Part 1-2: General requirements for safety- Collateral Standard: Electromagnetic compatibility - Requirements and tests. |
| Laser Safety (Diagnostic and Therapeutic Laser Equipment) | Tested and found compliant with IEC 60601-2-22:1995: Medical Electrical Equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment. |
| Laser Product Classification and Requirements | Tested and found compliant with IEC 60825-1:2007 (2nd edition): Safety of Laser Products-Part 1: Equipment Classification and Requirements. |
| Software Life Cycle Processes | Software documented, verified, and validated (test reports in submission) in accordance with IEC 62304:2006 - Medical Device Software: Software Life Cycle Processes. |
| Risk Management | Documented in accordance with ISO 14971:2012 – Application of Risk Management to Medical Devices. |
| Optional Tapered Light Guide Operation and Safety | Verified and validated (test reports in submission) in accordance with the design control and quality system principles of ISO 13485: 2012 - Medical Devices: Quality Management Systems and FDA federal regulation 21 CFR 820. |
Regarding the specific questions about clinical study design for performance:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document does not describe a clinical performance test set with human or biological data. The "tests" mentioned are engineering and software validation tests.
- 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): Not applicable. Ground truth for clinical efficacy is not discussed.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This device is a laser platform, not an AI-assisted diagnostic or therapeutic tool for which MRMC studies would be relevant in this context.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as detailed clinical performance is not assessed in this document. The "ground truth" for the engineering/software tests would be the requirements of the standards themselves.
- 8. The sample size for the training set: Not applicable. There is no machine learning or AI model being trained discussed.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this regulatory document focuses on establishing the safety, essential performance, and substantial equivalence of a modified laser platform to existing devices, primarily through engineering tests and comparison of technical specifications, rather than clinical performance studies against a "ground truth" for efficacy.
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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
{1}------------------------------------------------
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-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 | ✓ | 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,Halamish St. POB 302Industrial Park, 38900 |
|---|---|
| Contact Person: | Kathy MaynorConsultant352-586-3113 (cell) |
| Summary Preparation Date: | Aug 28, 2014 |
II. Names
| Device Names: | The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL,Soprano XLi and Soprano ICE] |
|---|---|
| Primary Classification Names: | Surgical Powered Light Instrument,Lamp, Infrared, Therapeutic Heating |
III. Predicate Devices
| K | # | Predicate Device |
|---|---|---|
| K112031 | Alma Lasers Modified Diode Laser Module with SHR TreatmentMode for use with the family of Soprano XL Multi-ApplicationPlatforms | |
| K102716 | Modified Alma Lasers Family of Soprano Family XLTM MultiApplication 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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-
- The main console unit
-
- Footswitch.
-
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
| K14Alma Lasers Modified 810nm DiodeLaser Module to be used with clearedSoprano XL and XLi Platform andproposed SopranoICE | K112031Alma Lasers Modified Diode Laser Module withSHR Treatment Mode used with the Soprano XLMulti-application Platforms | K102716Modified Alma Lasers Family ofSoprano Multi-Application Platforms[Soprano XLTM, Soprano XLiTM] | K083848Alma Lasers SopranoXL Multi-ApplicationPlatform | Parameter | K13Alma Lasers Modified 810nm Diode Laser Moduleto be used with cleared Soprano XL and XLiPlatform and proposed Soprano ICE | K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Modeused with the Soprano XL Multi-application Platforms | K102716Modified Alma Lasers Family of Soprano Multi-Application Platforms [Soprano XLTM, SopranoXLITM] | K083848Alma Lasers Soprano XL Multi-Application Platform | |
|---|---|---|---|---|---|---|---|---|---|
| ParameterProduct Code &Regulation No. | GEX21 CFR 878.4810 | GEX21 CFR 878.4810 | GEX21 CFR 878.4810 | GEX21 CFR 878.4810 | Product Code &Regulation No. | GEX21 CFR 878.4810 | GEX21 CFR 878.4810 | GEX21 CFR 878.4810 | GEX21 CFR 878.4810 |
| Diode ModuleModes | *SHR *HR *LB | SHR HR LB | HR LB | HR | Diode Module Modes | SHRHR | SHR HR LB | HR LB | HR |
| Laser Wavelength[nm] | 810(nominal) | 810(nominal) | 810(nominal) | 810(nominal) | Laser Wavelength [nm] | 810(nominal) | 810(nominal) | 810(nominal) | 810(nominal) |
| Light/LaserSource | Diode | Diode | Diode | Diode | Light/Laser Source | Diode | Diode | Diode | Diode |
| SpotSize[mm*mm] or[cm2] | 12*10 or 1.2, optional 6mm roundtapered light guide tip | 12*10 or 1.2 | 12*10 or 1.2 | 12* 10 or 1.2 | Spot Size[mm*mm] or[cm2] | 20*10 or 2 | 12*10 or 1.2 | 12*10 or 1.2 | 12* 10 or 1.2 |
| Fluence(Energy Density)[J/cm2] | 2-20 | 2-120 Up to 40 | $≤$ 10 $≤$ 120 | $≤$ 80 $≤$ 120 | Fluence(Energy Density)[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[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,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 |
| ExposureIndicator | Audible & visual indicator | Audible & visual indicator | Audible & visual indicator | Audible & visualindicator | Exposure Indicator | Audible & visual indicator | Audible & visual indicator | Audible & visual indicator | Audible & visual indicator |
| Compatible LaserSystem | Family of Soprano XL, XLi (cleared) &proposed SopranoICE | Family of Soprano XL and XLi MultiApplication | Family of Soprano XL and XLi MultiApplication Platforms | Soprano XL System | Compatible LaserSystem | Family of Soprano XL, XLi (cleared) & Soprano Ice | Family of Soprano XL and XLi Multi Application | Family of Soprano XL and XLi Multi ApplicationPlatforms | Soprano XL System |
| Dimensions[inches] | 6.694.81.9 | 6.755.752.5 | 6.755.752.5 | 6.755.752.5 | Dimensions ["] | 6.694.81.9 | 6.755.752.5 | 6.755.752.5 | 6.755.752.5 |
| 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 forUse | Permanent reduction inhair regrowth * | Treatment ofbenign vascular andpigmented lesions | Hair Removal, Permanenthair reduction Treatment ofbenign vascular andpigmented lesions | Hair Removal,Permanent hairreduction | Indications for Use | Permanent reduction in hairregrowth* | Hair Removal, Permanent hair reduction | Hair Removal,Permanent hair reduction | Hair Removal, Permanenthair 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 benignvascular andpigmented lesions | Treatment of benignvascular andpigmented lesions | Treatment of benign vascularand 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 12months 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
{8}------------------------------------------------
Table 3-1: Salient Characteristics of 755nm diode module and the predicate devices
| K13Alma Lasers 755nm Diode Module | K090571Alma Lasers ALEX755 Module | K083207Quantum Ultrawave III | |||||
|---|---|---|---|---|---|---|---|
| Parameter | GEX | GEX | |||||
| Product Code& Regulation No. | GEX21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | ||||
| Intended Use | HR and SHRPermanentreduction inhair regrowth* | LB Mode: Treatment of benignvascular and pigmented lesions | HR and SHR Mode :Hairremoval and permanenthair reduction | Treatment of benign vascularand pigmented lesions | Intended for coagulation and hemostatis of vascular lesions and the removal andpermanent reduction of unwanted hair in Fitzpatrick skin types I-VI, includingsuntanned skin types. Also indicated for pigmentedLesions and wrinkles. | ||
| Indicated for | all Skin Types (Fitzpatrick skin types I-VI), includingtanned skin | all skin types (Fitzpatrick skin types I-VI), including tanned skin | |||||
| Wavelength [nm] | 755 | 755 | 755 | ||||
| Light/LaserSource | Diode | Long Pulse Alexandrite | Long Pulse Alexandrite | ||||
| Beam Delivery | Direct | Direct | Direct | ||||
| Pulse Width[msec] | 3.3-200 | 3 - 100 | 3-100 | ||||
| Pulse RepetitionRate [Hz] | SHR:5-10 | HR:0.5-3 | LB2 | 2, 4 | upto 1.5 | ||
| Spot Size cm2 | 1.5 | 5mm round( . 79cm2) | 10mm(3.14cm2) | upto 16mm | |||
| Energy Density(Fluence) [J/cm2] | 2-202-120Up 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
| K13Alma Lasers 755nm Diode Mo dule | K090571Alma Lasers ALEX755 Module | K101916Sciton | ||||
|---|---|---|---|---|---|---|
| Parameter | ||||||
| Product Code& Regulation No. | GEX21 CFR 878.4810 | GEX21 CFR 878.4810 | GEX21 CFR 878.4810 | |||
| Intended Use | HR and SHR Mode | LB Mode: Treatment of benign vascular and pigmented lesionsPermanent 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 indicatedfor stable long term or permanent hair reduction for all skin types (Fitzpatrick I-VI)including tanned skin. It is also indicated for the treatment of vascular lesions, benignPigmented 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/LaserSource | Diode | Long Pulse Alexandrite | Long Pulse Alexandrite | |||
| Beam Delivery | Direct | Direct | Direct | |||
| Pulse Width[msec] | 3.3-200 | 3 - 100 | Up to 200msec | |||
| Pulse RepetitionRate [Hz] | SHR:5-10 | HR:0.5-3LB2 | 2, 4 | unk | ||
| Spot Size cm2 | 1.5 | 5mm round(.79cm2)10mm(3.14cm2) | 3mm, 6mm single spot, up to 30mm x 30mm scanned area | |||
| Energy Density(Fluence) [J/cm2] | 2-20 | 2-120Up to 25 | 328 | 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
| K13Alma Lasers NIR LargeModule | K080318Alma Lasers NIR Module | K050370Palomar LuxIR Hand piece | K042165Cutera Titan Tabletop ProductK033768 - Altus MedicalOptional 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)850-1350 (marketing material) | 850-3,000(filtered 1,100-1,800) |
| Lamp Type | Quartz Tube | Quartz tube | Quartz tube | Quartz tube |
| Intended Use | Intended to emit energy in the infraredspectrum to provide topical heating forthe purpose of elevating the tissuetemperature | Intended to emit energy in the infraredspectrum to provide topical heating for thepurpose of elevating the tissue temperature | Intended to emit energy in the infraredspectrum to provide topical heating forthe purpose of elevating the tissuetemperature | Intended to emit energy in theinfrared spectrum to providetopical heating for the purpose ofelevating the tissue temperature |
| Indications forUse | For the temporary relief of minor musclepain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation whereapplied, and the relaxation of muscles;may also help muscle spasms, minorsprains and strains, and minor muscularback pain. | For the temporary relief of minor musclepain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation where applied,and the relaxation of muscles; may alsohelp muscle spasms, minor sprains andstrains, and minor muscular back pain. | For the temporary relief of minor musclepain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation whereapplied, and the relaxation of muscles;may also help muscle spasms, minorsprains and strains, and minor muscularback pain. | For the temporary relief of minormuscle pain and joint pain andstiffness, the temporary relief ofminor joint pain associated witharthritis, the temporary increase inlocal circulation where applied,and the relaxation of muscles; mayalso help muscle spasms, minorsprains and strains, and minormuscular 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[mm*mm] or cm2] | 18 | 60 x 30 | 12 x 28 | 10 x 15; 10 x 30 |
| Cooling | Contact coolingThermo-electric (TEC) | Contact coolingThermo-electric (TEC) | Contact Cooling | Temperature regulated contactcooling |
| Treatment Mode | In-motion | In-motion | Stationary | Stationary |
| ExposureIndicator | 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 |
| ModuleDimensions | 1908056mm (LWH) | 1908056mm (LWH) | Not Available | Not Available |
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Table 5: Salient Characteristics of Alma Lasers NIR Small Module and the predicate devices
| K13Alma Lasers NIR Small Module | K080318Alma Lasers NIR Module | K050370Palomar LuxIR Hand piece | K042165Cutera Titan Tabletop ProductK033768 - Altus Medical OptionalInfrared Handpiece* | |
|---|---|---|---|---|
| Parameter | ||||
| Product Code &Regulation No. | ILY21 CFR 890.5500 | ILY21 CFR 890.5500 | ILY21 CFR 890.5500 | ILY21 CFR 890.5500 |
| Wavelength [nm] | 1300 | 800-1,800 | 800-1,800 (Cleared)850-1350 (marketing material) | 850-3,000(filtered 1 100-1 800) |
| Lamp Type | Quartz tube | Quartz tube | Quartz tube | Quartz tube |
| Intended Use | Intended to emit energy in the infraredspectrum to provide topical heating forthe purpose of elevating the tissuetemperature | Intended to emit energy in the infraredspectrum to provide topical heating for thepurpose of elevating the tissue temperature | Intended to emit energy in the infraredspectrum to provide topical heating forthe purpose of elevating the tissuetemperature | Intended to emit energy in theinfrared spectrum to provide topicalheating for the purpose of elevatingthe tissue temperature |
| Indications forUse | For the temporary relief of minor musclepain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation whereapplied, and the relaxation of muscles;may also help muscle spasms, minorsprains and strains, and minor muscularback pain. | For the temporary relief of minor musclepain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation where appliedand the relaxation of muscles; may alsohelp muscle spasms, minor sprains andstrains, and minor muscular back pain. | For the temporary relief of minormuscle pain and joint pain and stiffness, thetemporary relief of minor joint painassociated with arthritis, the temporaryincrease in local circulation whereapplied, and the relaxation of muscles;may also help muscle spasms, minorsprains and strains, and minor muscularback pain. | For the temporary relief of minormuscle pain and joint pain andstiffness, the temporary relief ofminor joint pain associated witharthritis, the temporary increase inlocal circulation where applied, andthe relaxation of muscles; may alsohelp muscle spasms, minor sprainsand strains, and minor muscular backpain. |
| Power Control | Time control | Time control | Time control | Exposure time |
| ModeFluence [J/cm²] | Pulsed.55-5.5 | Pulsed5.5 | PulsedUp to 100 | Pulsed5 - 65 |
| Pulse Width [sec] | 1-5 | 1 - 5 | 2.5 – 5 | Not available |
| Spot Size[mm*mm] or[cm²] | 6.4 | 60 x 30 | 12 x 28 | 10 x 15; 10 x 30 |
| Cooling | Contact coolingThermo-electric (TEC) | Contact coolingThermo-electric (TEC) | Contact Cooling | Temperature regulated contactcooling |
| Treatment Mode | In-motion | In-motion | Stationary | Stationary |
| ExposureIndicator | 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 |
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Safety and Effectiveness Information VII.
The review of the indications for use and technical characteristics provided demonstrates that the Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano ""] is substantially equivalent to the predicate devices. Additional safety testing was done as discussed in Section 18 of this submission.
The Soprano ICE was tested by a certified testing laboratory according to:
IEC 60601-1: 1988+A1:1991+A2:1995: Medical Electrical Equipment Part 1: General Requirements for basic safety and essential performance;
IEC 60601-1-2: Medical electrical equipment: Part 1-2: General requirements for safety- Collateral Standard: Electromagnetic compatibility - Requirements and tests (2001 + A1(4));
IEC 60601-2-22:1995 Medical electrical equipment - Part 2-22: Particular requirements for the safety of diagnostic and therapeutic laser equipment 1995; and
IEC 60825-1:2007 (2nd edition) Safety of Laser Products-Part 1: Equipment Classification and Requirements.
The software was documented, verified and validated (test reports in submission) in accordance with IEC 62304:2006 - Medical Device Software: Software Life Cycle Processes and ISO 14971:2012 – Medication of Risk Management to Medical Devices.
The optional tapered light guide was verified and validated (test reports in submission) for operation and safety in accordance with the design control and quality system principles of ISO 13485: 2012 - Medical Devices: Quality Management Systems and FDA federal regulation 21 CFR 820.
Conclusion VIII.
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano " and Soprano "E"] was found to be substantially equivalent to the predicate devices.
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano *** and Soprano " " shares the same or similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.
§ 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.