(7 days)
Not Found
No
The document describes a laser and light-based system with standard controls and cooling mechanisms. There is no mention of AI, ML, or any features that would suggest adaptive learning, image analysis for diagnosis, or other AI/ML functionalities.
Yes
The device is described as providing "temporary relief of minor muscle pain and joint pain and stiffness," and "temporary relief of minor joint pain associated with arthritis," which are therapeutic applications.
No.
The device is intended for therapeutic procedures such as hair removal, treatment of benign vascular and pigmented lesions, and topical heating for pain relief and circulation, not for diagnosing conditions.
No
The device description explicitly mentions hardware components such as a console, handpieces, footswitch, and a touch-screen control panel, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed on the patient's body (dermatologic and general surgical procedures, hair removal, treatment of lesions, pain relief, etc.). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a laser system that applies energy directly to the patient's skin. This is consistent with a therapeutic or aesthetic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms is a medical device, but it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Modified Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XLi] includes a Diode Laser Module and an optional NIR Module.
The Diode Laser Module:
The HR Mode is intended for hair removal, permanent hair reduction. The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions.
The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL, Soprano XLi] is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Product codes
GEX
Device Description
The Alma Lasers Soprano XLi system is a multi-application, multi-technology platform that supports the following technologies:
- Diode laser technology
- Near-infrared light technology (NIR) .
The Soprano XLi Diode Laser Module is intended for hair removal and long-term hair reduction, as well as for the treatment of benign vascular and pigmented lesions.
The Soprano XL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.
The Soprano XLi NIR Module is indicated to elevate the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The complete Soprano XLi platform consists of its console, two available module handpieces and a footswitch (refer to Figure 1). The module is pressed against the patient's skin and a light pulse is delivered when the handpiece trigger and/or the footswitch are activated. The handpiece tip is cooled to provide active and continuous skin cooling.
Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The review of the indications for use and technical characteristics provided demonstrates that the Modified Alma Lasers Family of Soprano XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
2010 SEP 288
CONFIDENTIAL
Appendix 7 - 510(k) Summary for Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano, Soprano XLi]
Summary Preparation Date: September 15, 2010
· General Information
| Sponsor/
| 510(k) Owner | Sponsor | ||
|---|---|---|---|
| Address and | |||
| Establishment | |||
| Registration # | Alma Lasers, Inc. | ||
| 485 Half Day Rd. Suite No. 100 | |||
| Buffalo Grove, IL 60089, USA | |||
| FDA Registration #: 3004167969 | |||
| Tatiana Epstein | |||
| VP QA&RA | |||
| Alma Lasers, Inc. | Telephone: | ||
| Facsimile: | |||
| Email: | (224 ) 377-2011 | ||
| (224 ) 377-2050 | |||
| tatianae@almalasers.com | |||
| Contact Person: | Main Contact: | ||
| Tatiana Epstein | |||
| VP QA&RA | |||
| Alma Lasers, Inc. | Telephone: | ||
| Facsimile: | |||
| Email: | (224 ) 377-2011 | ||
| (224 ) 377-2050 | |||
| tatianae@almalasers.com | |||
| Secondary Contact: | |||
| Avi Farbstein | |||
| EVP and GM North America | |||
| Alma Lasers, Inc. | Telephone: | ||
| Facsimile: | |||
| Email: | (224 ) 377-2011 | ||
| (224 ) 377-2050 | |||
| Avi.Farbstein@almalasers.com |
· Names
| Device Names: | Modified Alma Lasers Family of Soprano XL™ Multi-
Application Platforms [Soprano XL, Soprano XLi] |
|-------------------------------|------------------------------------------------------------------------------------------------------|
| Primary Classification Names: | Laser Instrument, Surgical, Powered; GEX
Lamp, Infrared, Therapeutic Heating |
· Predicate Devices
- Soprano Hair Removal Diode Laser system (K052874), cleared 11/22/2005, .
- . Alma Lasers Soprano XL Multi-Application Platform (K083848), cleared 04/14/2009
- Alma Lasers NIR Module (K080318), cleared 03/07/2008, .
· Product Description
The Alma Lasers Soprano XLi system is a multi-application, multi-technology platform that supports the following technologies:
- · Diode laser technology
- · Near-infrared light technology (NIR) .
The Soprano XLi Diode Laser Module is intended for hair removal and long-term hair reduction, as well as for the treatment of benign vascular and pigmented lesions.
The Soprano XL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.
The Soprano XLi NIR Module is indicated to elevate the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of
5 The Alma Lasers NIR Module is separately cleared under K080318.
Appendix 7: 510(k) Summary - Page 1 Special 510(k) Premarket Notification for: Alma Lasers Family of Soprano XL™ Multi-Application Platforms [Soprano XL, Soprano XLi]
1
minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The complete Soprano XLi platform consists of its console, two available module handpieces and a footswitch (refer to Figure 1). The module is pressed against the patient's skin and a light pulse is delivered when the handpiece trigger and/or the footswitch are activated. The handpiece tip is cooled to provide active and continuous skin cooling.
Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen.
· Indications for Use
The Modified Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] includes a Diode Laser Module and an optional NIR Module.
The Diode Laser Module:
The HR Mode is intended for hair removal, permanent hair reduction.
The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions.
The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL. Soprano XLi] is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
The intended use is identical to that previously cleared for the Soprano™ (K052874), Alma Lasers NIR Module (K080318) and Alma Lasers Soprano XL Multi-Application Platform (K083848).
The Indications for Use statement can be found in Appendix 4.
· Rationale for Substantial Equivalence
The Modified Alma Lasers Family of Soprano XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] has the following similarities to the previously cleared Soprano™ Hair Removal Diode Laser System (K052874), Alma Lasers NIR Module (K080318) and Alma Lasers Soprano XL Multi-Application Platform (K083848):
- Has the same intended use and indications for use, ■
- Uses the same operating principle (technology), .
- " Incorporates the same basic design,
- Incorporates the same materials, ■
- Is packaged using the same materials and processes. .
In summary, the Modified Alma Lasers Family of Soprano™ XL™ Multi-Application Platforms [Soprano XL, Soprano Xli] is substantially equivalent to the predicate devices.
2
• Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Modified Alma Lasers Family of Soprano XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] is substantially equivalent to the predicate devices.
· Conclusion
Modified Alma Lasers Family of Soprano XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] was found to be substantially equivalent to the predicate Soprano Family systems and devices.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle faces left and has a small, curved beak. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alma Lasers, Inc. % Ms. Tatiana Epstein Vice President, QA & RA 485 Half Day Road, Suite 100 Buffalo Grove, Illinois 60089
SEP 2 8 2010
Re: K102716
Trade/Device Name: Modified Alma Lasers Family of Soprano XL." Multi-Application Platforms Regulation Number: 21 CFR 878.34810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 16, 2010 Received: September 21, 2010
Dear Ms. Epstein:
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.
4
Page 2 - Ms. Tatiana Epstein
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K10
Modified Alma Lasers Family of Soprano™ Multi-Application Platforms Device Name: [Soprano XL, Soprano XLi]
Indications for Use:
The Modified Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of SOPRANO XL™ Multi-Application Platforms [Soprano XLi] includes a Diode Laser Module and an optional NIR Module.
The Diode Laser Module:
The HR Mode is intended for hair removal, permanent hair reduction. The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions.
The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
The Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL, Soprano XLi] is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Nil RP Splem for mxm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
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