(60 days)
Not Found
No
The document describes a laser device for dermatological procedures and hair removal. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for dermatologic and general surgical procedures, including hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions, which are all therapeutic uses.
No
The device is described as being for "dermatologic and general surgical procedures," including "hair removal, permanent hair reduction," and "treatment of benign vascular and pigmented lesions," which are all therapeutic interventions rather than diagnostic applications.
No
The device description clearly outlines hardware components such as a module housing, trigger switch, light guide, light guide retainer, and umbilical cable. This indicates it is a physical device with hardware, 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 hair removal, permanent hair reduction, and treatment of benign vascular and pigmented lesions. These are all procedures performed directly on the patient's body.
- Device Description: The device is a laser system designed to deliver energy to the treatment site on the patient. It includes components like a light guide, trigger switch, and umbilical cable for connecting to a console.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens and provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device operates in vivo (within the living body).
N/A
Intended Use / Indications for Use
The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms):
- The HR Mode is intended for hair removal, permanent hair reduction. .
- . The SHR Mode is intended for hair removal, permanent hair reduction.
- The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented . lesions.
The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms, and the delivery accessories that are used with it, is comprised of the following main components:
- A module housing with: .
- Module trigger switch (must be pressed at the same time the Soprano system A footswitch is depressed to deliver laser energy to the treatment site);
- A Light guide
- TEC-cooled to provide contact skin cooling 9
- A Light guide retainer
- Umbilical cable and connector that attaches the Diode Laser Module to the Soprano . system console and includes the electrical and cooling connections to the Soprano system.
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 supporting published information reported on clinical studies in 2,879 patients demonstrating the safety and effectiveness/performance of the 810 nm Diode Laser Module handpiece and the SHR Treatment Mode (used with the Soprano system console) for hair removal and permanent hair reduction.
These studies reported on the safety and effectiveness/performance immediately following treatment and at 1, 6, and 18 months following treatment with the 810 nm Diode Laser Module handpiece and the SHR treatment Mode (used with the Soprano system console) using the low fluence, high repetition rate, multiple-pass treatment regimen.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Appendix G - 510(k) Summary for the Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms
I. 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 | |||
| Contact | |||
| Person: | Tatiana Epstein | ||
| VP QA&RA | |||
| Alma Lasers, Inc. | Telephone: (224) 377-2011 | ||
| Facsimile: (224) 377-2050 | |||
| Email: Tatiana.epstein@almalasers.com |
September 13, 2011 Summary Preparation Date:
II. Names
Device Names:
Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms
| Primary Classification | |
|---|---|
| Names: | Laser Powered Surgical Instruments (and accessories) |
| 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 |
III. Predicate Devices
- Modified Alma Lasers Family of Soprano Multi-Application Platforms [Soprano � XLTM, Soprano XLi™] (K102716)
- Alma Lasers Soprano XL Multi-Application Platform (K083848) .
IV. Product Description
The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms, and the delivery accessories that are used with it, is comprised of the following main components:
- A module housing with: .
- Module trigger switch (must be pressed at the same time the Soprano system A footswitch is depressed to deliver laser energy to the treatment site);
- A Light guide
- TEC-cooled to provide contact skin cooling 9
- A Light guide retainer
- Umbilical cable and connector that attaches the Diode Laser Module to the Soprano . system console and includes the electrical and cooling connections to the Soprano system.
1
K112031 Pg 2 of 3
V. Indications for Use
The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms):
- The HR Mode is intended for hair removal, permanent hair reduction. .
- The SHR Mode is intended for hair removal, permanent hair reduction. ●
- The LaserBlanche Mode is intended for the treatment of benign vascular and . pigmented lesions.
The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
VI. Rationale for Substantial Equivalence
The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms shares the same indications for use, device operation, technical and functional capabilities, and therefore is substantially equivalent to the predicate Modified Alma Lasers Family of Soprano Multi-Application Platforms [Soprano XLTM, Soprano XLi™] (K102716) and the Alma Lasers Soprano XL Multi-Application Platform (K083848).
| Parameter | K11
Alma Lasers Modified Diode Laser Module
with SHR Treatment Mode used with the
Soprano XL Multi-Application Platforms | | | K102716
Modified Alma Lasers Family of
Soprano Multi-Application
Platforms [Soprano XLTM,
Soprano XLiTM] | | K083848
Alma Lasers
Soprano XL Multi-
Application
Platform | |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------|--|
| Diode
Module
Mode | SHR Mode | HR Mode | LB Mode | HR Mode | LB Mode | HR Mode | |
| Laser
Wavelength | 810 nm (nominal) | | | 810 nm (nominal) | | 810 nm (nominal) | |
| Indications
for Use | Intended for hair removal,
permanent hair reduction | | Intended for
treatment of
benign vascular
and pigmented
lesions | Intended for hair
removal,
permanent hair
reduction | Intended for
treatment of
benign vascular
and pigmented
lesions | Intended for hair
removal, permanent
hair reduction | |
| Soprano
System
Indications
for Use | • Intended for use in dermatologic and general surgical procedures
• Intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. | | | | | | |
| Spot Size | 1.2 cm2 | | | 1.2 cm2 | | 1.2 cm2 | |
| Fluence
(Energy
Density) | ≤ 10 J/cm2 | ≤ 120 J/cm2 | ≤ 80 J/cm2 | ≤ 120 J/cm2 | ≤ 80 J/cm2 | ≤ 120 J/cm2 | |
| Rep Rate | ≤ 10 Hz | ≤ 3 Hz | | ≤ 3 Hz | | ≤ 3 Hz | |
| Pulse
Duration | ≤ 20 ms | 5-200 ms | | 5-200 ms | | 5-200 ms | |
| Compatible
Laser Syst. | Used with Family of Soprano XL Multi-
Application Platforms | | | Family of Soprano XL Multi-
Application Platforms | | Soprano XL System | |
2
K112031 Pg 3 of 3
VII. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that the Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms is substantially equivalent to the predicate Modified Alma Lasers Family of Soprano Multi-Application Platforms [Soprano XL™] Soprano XLi™] (K102716) and the Alma Lasers Soprano XL Multi-Application Platform (K083848).
In addition, published peer-reviewed medical literature provided device validation information demonstrating that the changes do not raise new questions of safety or effectiveness.
The supporting published information reported on clinical studies in 2,879 patients demonstrating the safety and effectiveness/performance of the 810 nm Diode Laser Module handpiece and the SHR Treatment Mode (used with the Soprano system console) for hair removal and permanent hair reduction.
These studies reported on the safety and effectiveness/performance immediately following treatment and at 1, 6, and 18 months following treatment with the 810 nm Diode Laser Module handpiece and the SHR treatment Mode (used with the Soprano system console) using the low fluence, high repetition rate, multiple-pass treatment regimen.
VIII. Conclusion
The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms was found to be substantially equivalent to the predicate devices.
The Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of Soprano XL Multi-Application Platforms shares the same or similar indications for use, similar design features, and functional features with, and thus is substantially equivalent to the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is smaller than the central image.
Public Flealth Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Alma Lasers, Inc. % A. Worden Consulting Ms. Anne Worden 485 Half Day Road. Suite 100 Buffalo Grove, Illinois 60089
1 3 2511
Re: K112031
Trade/Device Name: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the Family of 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: Class II Product Code: GEX Dated: July 13, 2011
Received: July 15, 2011
Dear Ms. Worden:
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. Anne Worden
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 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/ucm115809.html 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 yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
pg 1 of 1
K11203 1 510(k) Number (if known):
Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Device Name: use with the Family of Soprano XL Multi-Application Platforms
Indications for Use:
The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms):
- The HR Mode is intended for hair removal, permanent hair reduction. .
- . The SHR Mode is intended for hair removal, permanent hair reduction.
- The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented . lesions.
The Alma Lasers Family of Soprano XL Multi-Application Platforms 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 o
ice of Device Evaluation (ODE)
Nailer Odom for mxen
orative Devices
510(k) Number K112031
Page 1 of l