(111 days)
No
The description focuses on laser and near-infrared light technology and system control via a microcontroller and touch-screen, with no mention of AI or ML.
Yes
The device is intended for the treatment of benign vascular and pigmented lesions and for the temporary relief of minor muscle pain and joint pain and stiffness, etc., which are therapeutic purposes.
No
The device is described as a "Multi-Application Platform" intended for treatment rather than diagnosis. Its functions include hair removal, treatment of lesions, temporary relief of pain and stiffness, and temporary increase in circulation. These are all therapeutic applications, not diagnostic ones.
No
The device description explicitly states it includes hardware components such as a console, diode module, NIR module, and footswitch, in addition to software controlled via a touch-screen.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of any actual or potential recipient, or to monitor therapeutic measures.
- SOPRANO XL™ Function: The SOPRANO XL™ Multi-Application Platform is a laser and light-based system that applies energy directly to the patient's body for therapeutic purposes (hair removal, lesion treatment, pain relief, etc.). It does not examine specimens in vitro.
The device description and intended use clearly indicate that it is a therapeutic device used for direct treatment on the patient's skin and underlying tissues.
N/A
Intended Use / Indications for Use
The SOPRANO XL™ Multi-Application Platform 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 SOPRANO XL™ Multi-Application Platform is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Product codes
GEX
Device Description
The Soprano XL Multi-Application Platform features an additional indication for the treatment of benign vascular and pigmented lesions introduced to its Diode Module compared to the existing Alma Lasers, Ltd. (former MSq., Ltd.) Soprano Diode Laser System, previously cleared under K052874 for hair removal and long-term hair reduction. The Soprano XL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.
The Soprano XL Multi-Application Platform is a multi-application, multi-technology platform that supports the following technologies:
- · Diode laser technology
- · Near-infrared light technology (NIR)2.
Both the Soprano and Soprano XL systems consist of a console, a diode module and a footswitch. The module is pressed against the patient skin and a laser pulse is delivered when the module trigger and the footswitch are activated. The module tip is cooled by the cooling system.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K001746, K003614, K013028, K050900, K052874, K053628
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.
0
16083848♡
. APR 1 4 2009
Section 5 - 510(k) Summary or 510(k) Statement
I. General Information
Submitter:
Alma Lasers, Ltd. Halamish Street (PO Box 3021), Industrial Park, Caesarea, 38900 ISRAEL
| Contact Person: | Tatiana Epstein
Regulatory Affairs Manager,
Alma Lasers, Ltd. |
| ----------------- | --------------------------------------------------------------------- |
|---|
December 20th, 2008 Summary Preparation Date:
- II. Names
Device Names: Alma Lasers Soprano XL Multi-Application Platform
Primary Classification Names: Laser Instrument, Surgical, Powered
III. Predicate Devices
- · K001746 LightSheer Pulsed Diode Array Laser System Lumenis, Inc. (formerly Coherent Star)
- · K003614 LightSheer Pulsed Diode Array Laser System Lumenis, Inc. (formerly Coherent Star)
- · K013028 Palomar SLP™ 1000 -- Palomar Medical Technologies, Inc.
- · K050900 MeDioStar XL Asclepion Laser technologies, GmbH.
- · K052874 · Soprano Hair Removal Diode Laser System Alma Lasers, Ltd. (formerly MSq., Ltd.)
- · K053628 LightSheer Duet™ Laser System Lumenis, Inc.
IV. Product Description
The Soprano XL Multi-Application Platform features an additional indication for the treatment of benign vascular and pigmented lesions introduced to its Diode Module compared to the existing Alma Lasers, Ltd. (former MSq., Ltd.) Soprano Diode Laser System, previously cleared under K052874 for hair removal and long-term hair reduction. The Soprano XL system is indicated for use on all skin types (Fitzpatrick Skin Types I-VI), including tanned skin.
The Soprano XL Multi-Application Platform is a multi-application, multi-technology platform that supports the following technologies:
- · Diode laser technology
- · Near-infrared light technology (NIR)2.
Premarket Notification, 510(k) Submission for: Alma Lasers Soprano XL Multi-Application Platform Section 5: 510(k) Summary - Page 1
2 The Soprano XL NIR Module is cleared separately under K080318.
1
Both the Soprano and Soprano XL systems consist of a console, a diode module and a footswitch. The module is pressed against the patient skin and a laser pulse is delivered when the module trigger and the footswitch are activated. The module tip is cooled by the cooling system.
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.
V. Indications for Use
The SOPRANO XL™ Multi-Application Platform 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 SOPRANO XL™ Multi-Application Platform is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
VI. Rationale for Substantial Equivalence
The Alma Lasers Soprano XL Multi-Application Platform shares the same indications for use, the operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate devices.
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Soprano XL Multi-Application Platform is substantially equivalent . to the predicate devices.
VIII. Conclusion
The Alma Lasers Soprano XL Multi-Application Platform was found to be substantially equivalent to the predicate devices.
The Alma Lasers Soprano XL Multi-Application Platform shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.
2
Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with three curved lines representing the eagle's wings and body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2009
Alma Lasers, Ltd. % Ms. Tatiana Epstein RA Manager Halamish Street, P.O. Box 3021 Industrial Park Caesarea 38900 Israel
Re: K083848
Trade/Device Name: Alma Lasers Soprano XL™ Multi-Application Platform Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 24, 2009 Received: March 26, 2009
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
3
Page 2 - Ms. Tatiana Epstein
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliaring at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities inder the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millhuss
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): K083848
Device Name: Alma Lasers Soprano XLTM Multi-Application Platform
Indications for Use:
The SOPRANO XLTM Multi-Application Platform 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 SOPRANO XL™ Multi-Application Platform is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Prescription Use (Part 21 CFR 801 Subpart D)
510(k) Number
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)
for mkm
(Division Fgn-Off)
Division of General, Restorative,
and Neurological Devices
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