(90 days)
No
The document describes a laser device for hair removal and dermatological procedures. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The performance studies focus on electrical and laser safety standards, not algorithmic performance.
Yes
The device is intended for the treatment of Pseudo folliculitis Barbae (PFB), which is a medical condition.
No
The device is a laser module intended for dermatologic and general surgical procedures, specifically for hair removal and treatment of Pseudo folliculitis Barbae (PFB). It is a therapeutic device, not a diagnostic one.
No
The device is a laser module, which is a hardware component that emits laser energy. While it includes software for operation, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatologic and general surgical procedures," specifically for hair removal and treatment of pseudofolliculitis barbae. This involves direct interaction with the patient's body for therapeutic purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests.
- Device Description: The device is a laser module that emits energy to the patient's skin. This is a physical intervention, not a diagnostic test on a sample.
- Lack of Diagnostic Language: The document does not mention any diagnostic purpose, analysis of biological samples, or detection of medical conditions through testing.
Therefore, the Soprano 1064nm Diode Laser Module is a therapeutic device used for dermatological procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use
The additional Soprano 1064nm Diode Laser Module is intended for use in dermatologic and general surgical procedures.
Indications for Use
The indications for use for the Soprano1064nm Diode Laser Module include:
- 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.
- Treatment of Pseudo folliculitis Barbae (PFB)
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.
Product codes
GEX, ILY
Device Description
The subject device, Alma Lasers Soprano 1064nm Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano 100 platform. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, footswitch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module; the footswitch and pre-existing modules are also unmodified from those cleared in K140009.
The module's operation involves emission of laser (diode) energy through the handpiece to the patient's skin. The materials that could contact the patient during device use are sapphire, aluminum, and plastic; these would all have limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
user facilities such as hospitals, physicians' offices and medical spas
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)
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for basic safety and essential performance Ed 3.1
IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance Ed 4.0
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Ed 3.1
IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General requirements for safety Ed. 3.1 IEC 60825-1 Safety of laser products-Part 1: Equipment Classification and requirements Ed 2.0
In addition software verification and validation testing was performed and biocompatibility was established.
In all instances, the Soprano 1064nm Diode Laser Module functioned as intended and the results observed were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The text is left-aligned and in a simple font.
May 31, 2017
Alma Lasers Inc. Rekha Anand Sr. Regulatory Affairs Associate 485 Half Dav Road Suite # 100 Buffalo Grove, Illinois 60089
Re: K170626
Trade/Device Name: Modified Alma Lasers Soprano XL Family Of Multi-application & Multi-technology Platform, Soprano Yag Hand Piece 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: February 27, 2017 Received: March 2, 2017
Dear Rekha Anand:
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 Actinclude 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
Image /page/0/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three overlapping profiles facing to the right.
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Sincerely.
Jennifer R. Stevenson -S
For 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
2
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K170626
Device Name
Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano™ Soprano " , and Soprano"CE] with 1064nm Diode Laser Module.
Indications for Use (Describe)
Intended Use
The additional Soprano 1064nm Diode Laser Module is intended for use in dermatologic and general surgical procedures.
Indications for Use
The indications for use for the Soprano1064nm Diode Laser Module include:
- = The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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.
- Treatment of Pseudo folliculitis Barbae (PFB)
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 8 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Owner Name | Alma Lasers Inc. |
|---|---|
| Address | 485 Half Day Rd. Suite 100 |
| Buffalo Grove, IL 60089 | |
| Contact Person | Rekha Anand |
| Senior Regulatory Affairs Associate | |
| Email : regulatory@almalasers.com | |
| Phone: 224-377- 2019 or 2150 | |
| Facsimile: 646-805-1305 | |
| Summary Preparation Date | February 27, 2017 |
I. Submitter Information [21 CFR 807.92(a) (1)]
Name of device [21 CFR 807.92 (a) (2)] II.
| Trade or Proprietary Name | Modified Alma Lasers Soprano XL TM Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano XLi, and Soprano ICE] with 1064nm Diode Laser Module, Soprano YAG hand piece | ||
|---|---|---|---|
| Common Device Name(s) and | |||
| Regulatory Class | Product | ||
| Code(s) | Classification Panel | Regulation | |
| Laser Powered Surgical | |||
| Instruments (& Accessories) | |||
| Class II | GEX | General & Plastic | |
| Surgery Panel, 79 (SU) | § 878.4810, Laser surgical | ||
| instrument for use in general and | |||
| plastic surgery and dermatology | |||
| Surgical Powered Lasers and Delivery Devices/Hand piece | |||
| Accessories | |||
| Lamp, Infrared, Therapeutic | |||
| Heating | |||
| Class II | ILY | General & Plastic | |
| Surgery Panel, 79 (SU) | § 890.5500-Lamp, Infrared, | ||
| Therapeutic Heating | |||
| Lamp, Infrared |
III. Predicate Devices [21 CFR 807.92(a) (3)]
| Type | 510(k) # | Trade Name | Product
Code |
|-----------|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Primary | K153671,
K132185 | Family of Coolglide Aesthetic Lasers | GEX |
| Reference | K140009 | Modified Alma Lasers Soprano XL™ Family of
Multi-Application and Multi-Technology Platforms
[Soprano XL, Soprano XLi, and Soprano ICE] | GEX,ILY |
Premarket Notification, Traditional 510(k)
Section 8: Page 1 of 5
Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano X, Sopranoxii, and SopranolCF] with 1064nm Diode Laser Module.
4
IV. Device Description [21 CFR 807.92(a) (4)]
The subject device, Alma Lasers Soprano 1064nm Diode Laser Module is an additional hand piece intended to be used with previously cleared Soprano 100 platform. Consistent with the previous clearance the system is intended to be used in user facilities such as hospitals, physicians' offices and medical spas, and its major components are still the main console unit, footswitch, and individual modules. No change has been made to the main console unit except for incorporation of the software needed to run the new module; the footswitch and pre-existing modules are also unmodified from those cleared in K140009.
The module's operation involves emission of laser (diode) energy through the handpiece to the patient's skin. The materials that could contact the patient during device use are sapphire, aluminum, and plastic; these would all have limited-duration surface contact with intact skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.
V. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)]
Intended Use
The Soprano 1064nm module is intended for use in dermatologic and general surgical procedures.
Indications for Use
The indications for use for the 1064nm Diode Laser Module include:
- 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 in HR and SHR Modes
- Treatment of Pseudo folliculitis Barbae (PFB)
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.
There is no change in intended use and indications for the existing Diode 810nm, 755nm and NIR hand pieces.
VI. Summary of technological characteristics of the device compared to the predicate[21 CFR 807.92(a)(6)]
There is no change in intended use or indications for the existing 810nm and 755nm diode laser hand pieces or the near-infrared light (NIR) hand pieces of the cleared Soprano10 platform. Thus, there is only an addition of a new diode 1064 module and only new indication being added through the subject device is treatment of PFB. This additional indication does not impact the device's overall intended therapeutic/surgical use, because it is a surface dermatological procedure like those previously cleared. The new indication also does not affect
Premarket Notification, Traditional 510(k)
5
the safety and effectiveness of the device when used as labeled, because the primary predicate is already cleared for treating PFB, and the subject device mechanism of action for this indication is the same as for the diode laser modules previously cleared in the primary predicate. The Soprano 1064nm diode laser module also has fewer indications for use as compared to the primary predicate at 1064nm, but this omission does not impact the subject module's safety or effectiveness since all of its proposed indications are encompassed by the predicate.
The technological principles underlying the subject device and its prior legally marketed iteration (the Soprano se platform cleared in K140009) are the same. Operation of the new 1064nm diode laser module involves delivery of diode laser energy through the tip built into the corresponding handpiece, just as use of the device with the previously cleared laser modules involves delivery of laser energy through the different-sized tips of the selected handpiece, or through the tapered light guide tip for treating smaller areas. The NIR modules have not been modified since their clearance in K140009; they emit pulsed-light energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, temporary increase in local circulation, and muscle relaxation. The non-laser functions of the Soprano and CoolGlide devices are not implicated in this submission, which focuses only on the proposed new 1064nm diode laser module for the Soprano CE platform.
The only technological difference in the subject device as compared to the prior iteration of the Soprano CE platform (K140009) is addition of a new wavelength (1064nm) to its diode laser functionality. This difference does not raise new questions of safety or effectiveness, because the new module functions in exactly the same way as the laser modules previously cleared, and the primary predicate's clearance includes use of laser energy at 1064nm for the same indications as are proposed for the Soprano 1064nm Diode Laser Module.
A table comparing the key features of the subject and reference/primary predicate devices is provided on the following page.
Premarket Notification, Traditional 510(k)
6
| Characteristic¹ | Proposed Soprano 1064nm Diode Laser Module | Reference Predicate SopranoICE (K140009) | Predicate Family of Coolglide Aesthetic Lasers (K153671), (K132185) |
|---|---|---|---|
| Wavelength [nm] | 1064 | 810, 755 | 1064 |
| Laser Media | Solid State | Solid State | Solid State |
| Mode | HR SHR | HR SHR LB | |
| Spot Size | 10mm * 10mm (1cm²) | ||
| Optional tapered tip 6mm (0.28 cm²), | 810nm: | ||
| 12*10mm (1.2cm²), | |||
| 20 *10 mm(2cm²) | |||
| Optional tapered tip 6mm (0.28cm²), 12 | |||
| 755nm: | |||
| 15*10mm (1.5cm²) | K153671 Clearance letter: | ||
| 3mm(0.07cm²), 4mm(0.12cm²), 5mm(0.2cm²), 6mm(0.28cm²), | |||
| 7mm(0.38cm²), 8mm(0.5cm²), 9mm(0.64cm²), 10mm(0.8cm²), | |||
| 11mm(0.95cm²), 12mm(1.13cm²), 13mm(1.32cm²), 14mm(1.54cm²), | |||
| 15mm(1.7cm²), 16mm(2cm²), 17mm(2.27cm²), 18mm(2.54cm²) | |||
| K132185 clearance letter: | |||
| 3mm(0.07cm²),5mm(0.2cm²)8mm(0.5cm²).10mm(0.8cm²),12mm(1.13cm²) | |||
| Pulse Width [msec] | 3.3-280 | 3.3-200 | K153671: Not available, K132185: 01.-300 |
| Pulse Repetition Rate [Hz] | 0.5-3 5-10 | 0.5-3 5-10 2 | ≤ 10 Hz and single shot |
| Energy Density (Fluence) [J/cm²] | 2-120 2 to 20 | 2-120 2-20 810nm-up to 40 | |
| 755nm-up to 25 | K153671: Not Available, K132185: Up to 300 | ||
| User Interface | LCD Color Touchscreen | LCD Color Touchscreen | Push Button Control or LCD Color Touchscreen |
| Delivery Devices (How supplied) | Non-Sterile, reusable, cleanable | Non-Sterile, reusable, cleanable | Non-Sterile, reusable, cleanable |
| Compatible Laser System | Family of SopranoXL, SopranoXLi and SopranoICE (cleared K 14009) | Family of SopranoXL, SopranoXLi, and SopranoICE (cleared K 14009) | Coolglide System |
| Indications for use | • Permanent reduction ² in hair regrowth in HR and SHR Mode | ||
| • Treatment of Pseudo folliculitis Barbae (PFB) | |||
| • Use on all skin types (Fitzpatrick I-VI), including tanned skin | • Permanent reduction in hair regrowth in HR and SHR Mode | ||
| • Treatment of vascular and pigmented lesions in LB Mode | |||
| • Use on all skin types (Fitzpatrick I-VI), including tanned skin | • Permanent reduction in hair regrowth | ||
| • Treatment of Pseudo folliculitis Barbae (PFB | |||
| • Treatment of vascular and pigmented lesions³ | |||
| • Treatment of wrinkles, such as, but not limited to periocular and perioral wrinkles. | |||
| • Treatment of mild to moderate inflammatory acne vulgaris | |||
| • Use on all skin types (Fitzpatrick I-VI), including tanned skin |
Only the specifications/parameters relevant to this submission (corresponding to the 1064nm wavelength) are provided in this table.
Premarket Notification, Traditional 510(k)
Section 8: Page 4 of 5
Modified Alma Lasers Soprano XL™ Family of Multi-Technology Platforms (Soprano™, and Soprano™, and Soprano™, and Soprano™, and Soprano™ (104mm Dide Laser Module.
" Permanent reduction in hair regrowth is defined as a long-term, stable reduction in the number of harmesured at 6,9 and 12 morth after the completion of a treatment regimen
3 Benign vascular lesions, such as, but not limited to, port, telangiectasis, rosacea, venus late, leg veins, spider veins, and poiklocema of civate; and treatment of benign cutaneous lesions such, scars, strae, and porizas. Benign pigmented lesions swch as, but not limited to lentigos, solar lentigos, café au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos and plaques.
7
VII. Performance Testing [21 CFR 807.92(b)(1)]
IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for basic safety and essential performance Ed 3.1
IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance Ed 4.0
IEC 60601-2-22 Medical Electrical Equipment-Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment Ed 3.1
IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General requirements for safety Ed. 3.1 IEC 60825-1 Safety of laser products-Part 1: Equipment Classification and requirements Ed 2.0
In addition software verification and validation testing was performed and biocompatibility was established.
In all instances, the Soprano 1064nm Diode Laser Module functioned as intended and the results observed were as expected.
VIII. Clinical Data [21 CFR 807.92(b) (2)]
Based on the similarities in the safety and effectiveness profiles of the subject, reference, and primary predicate devices, no animal or clinical studies were deemed needed to support this submission.
IX. Conclusions Safety and Effectiveness SE [21 CFR 807.92(b) (3)]
The Soprano 1064nm Diode Laser Module is as safe and effective as the Cutera Family of CoolGlide Aesthetic Lasers (K132185, K153671) ("primary predicate device") and the Alma Lasers Soprano XL™ Family of Multi-Application Platforms [Soprano™, Soprano™, and Soprano (6) (K140009) ("reference device"). The proposed 1064nm module has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate and reference devices. The minor differences in indications do not alter the intended therapeutic/surgical use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the Soprano 1064nm Diode Laser Module and its predicate/reference devices raise no new issues of safety or effectiveness. Thus, the Soprano 1064nm Diode Laser Module is substantially equivalent.
Premarket Notification, Traditional 510(k)