(91 days)
Not Found
No
The document describes a laser system for dermatology procedures and hair removal. There is no mention of AI, ML, or image processing, and the performance studies focus on hair count reduction, not algorithmic performance.
Yes
The device explicitly states indications for use that include "temporary relief of minor muscle pain and stiffness," "temporary relief of minor joint pain associated with arthritis," "temporary increase in local circulation where applied," and "relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain," all of which qualify as therapeutic benefits.
No
The device is intended for therapeutic procedures such as hair reduction, coagulation, and temporary relief of pain and stiffness, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of a console containing laser diodes, power supply, and other electronic and mechanical parts, in addition to the system software. This indicates it is a hardware 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:
- 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.
- Device Function: The Soprano Titanium laser system is a medical device that uses laser energy for therapeutic purposes, specifically:
- Hair removal/reduction
- Coagulation in dermatology procedures
- Treatment of benign vascular lesions
- Topical heating for pain relief, circulation, and muscle relaxation.
- Mechanism of Action: The device directly interacts with the patient's tissue using laser energy. It does not analyze samples taken from the body.
The description clearly outlines the device's use in direct patient treatment and procedures, which falls under the category of therapeutic medical devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include:
The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.
The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode include: Benign vascular and vascular dependent lesions.
810nm Applicator
Soprano Titanium 810 nm applicator intended use and indications for use:
The indications for use for the 810nm Modified Diode Laser Module 2 cm2 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.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
755nm applicator
Soprano Titanium 755 nm applicator intended use and indications for use:
The indications for use for the 755nm 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.
· Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)
NIR Applicator
NIR Applicator intended use and indications for use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ILY
Device Description
The Alma Lasers Soprano Titanium Laser System consists of:
- · System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts)
- · Operator control panel with touch-screen technology (GUI)
- · Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously
- 810 nm applicator
- 755 nm applicator ●
- Small NIR applicator
- Footswitch and other laser safety accessories ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
axilla and bikini line
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
A total of 60 treatment areas were evaluated by 3 evaluators.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Alma Lasers sponsored a human clinical study for hair removal using the Soprano Titanium applicator (SHR mode) that delivers three wavelengths simultaneously. The US study was conducted at two sites as a multi-center, prospective, open label, single arm study consisting of thirty (30) healthy subjects. Treatment areas included the axilla and bikini line (two treatment areas for each subject).
Following the screening visit, eligible subjects were enrolled into the study. Each subject received 4 hair removal treatments, every 6 weeks. Safety and efficacy was evaluated at the follow-up visit that took place 3 months after the last treatment.
Hairs were physically counted, and three blinded evaluators assessed the results compared to the baseline for each treatment area.
A total of 60 treatment areas were evaluated by 3 evaluators. Statistically significant percent reduction in hair count in all sections from baseline to 3 months was shown with an average reduction of -42.7%±17.1, range (-77.9-36.5), p
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 12, 2022
Alma Lasers Inc. % Kathy Maynor Regulatory consultant Kathy Maynor consulting 26 Rebecca Ct Homosassa, Florida 34446
Re: K222064
Trade/Device Name: The Alma Soprano Titanium 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: March 1, 2022 Received: July 13, 2022
Dear Kathy 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222064
Device Name Soprano Titanium
Indications for Use (Describe)
The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include:
The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.
The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode include: Benign vascular and vascular dependent lesions.
810nm Applicator
Soprano Titanium 810 nm applicator intended use and indications for use:
The indications for use for the 810nm Modified Diode Laser Module 2 cm2 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.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
755nm applicator
Soprano Titanium 755 nm applicator intended use and indications for use:
The indications for use for the 755nm 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.
· Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)
NIR Applicator
NIR Applicator intended use and indications for use
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 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K222064
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 | Kathy Maynor |
| Regulatory Consultant | |
| Email : regulatory@almalasers.com | |
| Phone: 352-586-3113 | |
| Facsimile: 646-805-1305 | |
| Summary Preparation Date | July 11, 2022 |
I. Submitter Information [21 CFR 807.92(a) (1)]
II. Name of device [21 CFR 807.92 (a) (2)]
| Trade or Proprietary Name | Soprano Titanium | ||
|---|---|---|---|
| Common Device Name(s) and | |||
| Regulatory Class | Product | ||
| Code(s) | Classification Panel | Regulation | |
| Powered Laser Surgical | |||
| Instrument Class II | GEX | General & Plastic | |
| Surgery Panel, 79 | |||
| (SU) | § 21 CFR 878.4810 | ||
| Lamp, Infrared Therapeutic | |||
| Heating Class II | ILY | General & Plastic | |
| Surgery Panel, 79 | |||
| (SU) | § 21 CFR 890.550 |
III. Predicate Devices [21 CFR 807.92(a) (3)]
| Type | 510(k) # | Trade Name | Product
Code |
|---------|----------|----------------------|-----------------|
| Primary | K172193 | Soprano Ice Platinum | GEX |
IV. Device Description [21 CFR 807.92(a) (4)]
The Alma Lasers Soprano Titanium Laser System consists of:
- · System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts)
- · Operator control panel with touch-screen technology (GUI)
- · Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously
5
- 810 nm applicator
- 755 nm applicator ●
- Small NIR applicator
- Footswitch and other laser safety accessories ●
V. Intended use of device and Indications for Use [21 CFR 807.92(a) (5)] Indications for Use
Trio SHR Mode intended use and indications for use:
The Soprano Trio diode laser module with SHR mode is intended for use in dermatology procedures requiring coagulation. The indications for the Soprano Trio diode laser module include:
The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.
Trio HR Mode intended use and indications for use:
The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser HR module include:
Benign vascular and vascular dependent lesions
The 810 nm applicator intended use and indications for use:
The indications for use for the 810nm Modified Diode Laser Module 2 cm2 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.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR. and SHR Modes)
The 755 nm applicator intended use and indications for use:
The indications for use for the 755nm 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.
- · Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)
NIR Applicator intended use and indications for use:
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.
6
- . 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.
VI. Summary of technological characteristics of the device compared to the predicate [21 CFR 807.92(a)(6)]
The subject Soprano Titanium system shares with its predicate Soprano Ice Platinum system (K172193) the same underlying technology and presents very similar technological characteristics. Both systems use laser energy, delivered to the skin surface, via applicators.
Specifically, the subject Soprano Titanium is substantially equivalent to the cleared Soprano Ice Platinum system with respect to the hardware and software elements of the system, the principles of operation and the product design. Both the subject Soprano Titanium and the predicate Soprano Ice Platinum have the same main functional components consisting of a system console with a user interface, laser and NIR modules, internal electronics and laser and NIR applicators.
As noted previously, the Soprano Titanium system is a subset of the cleared predicate Soprano Ice Platinum system in that it does not support the 1064nm and 810nm 1.2 cm2 applicators. The Soprano Titanium system does use the same 755nm, 810mm and NIR small applicator as the predicate Soprano Ice Platinum system.
The Soprano Trio applicator (initially cleared in K172193 as part of the Soprano Ice Platinum system) has a change in spot size from 1cm2 to 4 cm2 . The Soprano Trio applicator was previously cleared for benign vascular and vascular dependent lesions removal (K172193). This 510(k) includes a summary of a human clinical study performed to add a hair removal indication to the SHR mode of the Trio applicator. The human clinical study included the 4 cm2 spot size, and it was performed in accordance with the well-established FDA methodology for conducting and accepting hair removal clinical studies. Additionally, the protocol was reviewed by the FDA in Q181225 prior to its use. The addition of this indication for use does not affect safety or efficacy.
The HR mode of the Trio applicator is indicated for benign vascular and vascular dependent lesions just as the predicate Trio applicator in K172193.
There are a few very minor changes to the 755nm applicator (deletion of laser blanch mode) and 810nm 2 cm2 applicator (deletion of laser blanch mode, deletion of the 1.2 cm2 spot size) and no change to the small NIR applicator. These changes do not affect safety and efficacy.
VII. Performance Testing [21 CFR 807.92(b)(1)]
IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance IEC 60601-1-2 Medical electrical equipment – Part 1-2 General
7
requirements for safety and essential performance - Collateral standard: Electromagnetic compatibility 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 IEC 60825-1, Safety of laser products - Part 1: Equipment classification, and requirements ISO10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
In addition software verification and validation testing was performed and biocompatibility was established.
VIII. Clinical Data [21 CFR 807.92(b) (2)]
Alma Lasers sponsored a human clinical study for hair removal using the Soprano Titanium applicator (SHR mode) that delivers three wavelengths simultaneously. The US study was conducted at two sites as a multi-center, prospective, open label, single arm study consisting of thirty (30) healthy subjects. Treatment areas included the axilla and bikini line (two treatment areas for each subject).
Following the screening visit, eligible subjects were enrolled into the study. Each subject received 4 hair removal treatments, every 6 weeks. Safety and efficacy was evaluated at the follow-up visit that took place 3 months after the last treatment.
Hairs were physically counted, and three blinded evaluators assessed the results compared to the baseline for each treatment area.
A total of 60 treatment areas were evaluated by 3 evaluators. Statistically significant percent reduction in hair count in all sections from baseline to 3 months was shown with an average reduction of -42.7%±17.1, range (-77.9-36.5), p