(239 days)
No
The document describes a laser and NIR platform for dermatologic and general surgical procedures, focusing on hair removal, vascular/pigmented lesion treatment, and topical heating. There is no mention of AI or ML in the intended use, device description, or any other section provided.
Yes
The device is described as treating benign vascular and pigmented lesions and providing temporary relief for minor muscle/joint pain, stiffness, and associated with arthritis, which constitutes therapeutic intent.
No
The "Intended Use / Indications for Use" section describes the device for therapeutic purposes (hair removal, treatment of lesions, pain relief, etc.) rather than for diagnosing conditions.
No
The device description explicitly lists hardware components such as a main console unit and footswitch, and the intended use involves physical interaction with tissue using laser and NIR modules.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Intended Use: The intended use of the Modified Alma Lasers Soprano XL™ Family is for "dermatologic and general surgical procedures." The specific indications for use listed are for:
- Hair removal
- Treatment of benign vascular and pigmented lesions
- Temporary relief of minor muscle and joint pain and stiffness
- Temporary relief of minor joint pain associated with arthritis
- Temporary increase in local circulation
- Relaxation of muscles
These are all procedures performed directly on the body, not tests performed on samples taken from the body. The device uses laser and near-infrared energy to interact with tissue, which is characteristic of therapeutic or aesthetic devices, not IVDs.
N/A
Intended Use / Indications for Use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano de, Soprano de and Soprano (5) is intended for use in dermatologic and general surgical procedures.
Indications for Use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano ^', Soprano * and Soprano "CE] includes Diode Laser and NIR Modules
Diode Laser Modules:
The indications for use for the 810mm Modified Diode Laser Module 1.2 cm² include:
- The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch (LB) Mode)
. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR. SHR and LB Modes)
Optional Tapered Light Guide: It is intended for the same use as the device.
The indications for use for the 810nm Modified Diode Laser Module 2 cm² include:
- . The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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 indications for use for the 755nm Diode Laser Module include:
- The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode) 트
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes) .
NIR Modules
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, 트
- The temporary relief of minor joint pain associated with arthritis,
- 프 The temporary increase in local circulation where applied, and
- 미 The relaxation of muscles; may also help muscle spasms, minor sprains and minor muscular back pain.
Product codes
GEX, ILY
Device Description
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano ™ and Soprano "CE] is a modification to previously cleared Soprano Family XL ™M Multi Application Platform [Soprano **] The relevant K number is K102716.
Soprano 40, the new addition to the family has hand pieces with multiple wavelengths, spot sizes and supports both Diode Laser and Near Infrared (NIR) Technologies. The Soprano 40 comprises of the following major components:
-
- The main console unit
-
- Footswitch.
-
- Hand pieces
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K112031, K102716, K083848, K080318
Reference Device(s)
K090571, K101916, K083207, K050370, K042165, K033768
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
Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, layered on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2014
Alma Lasers Ltd % Kathy Maynor Consultant 26 Rebecca Court Homosassa, Florida 34446
Re: K140009 Trade/Device Name: The Modified Alma Lasers XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano 31 Soprano 10 and Soprano 105] 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: April 26, 2014 Received: June 3, 2014
Dear Ms. 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. 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 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
1
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 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/Resourcesfor You/Industry/default.htm. 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 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.
for
Sincerely yours,
David Krause -S
- 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
| 510(k) Number (if known): | K140009 |
|---|---|
| Device Name: | The Modified Alma Lasers Soprano XLTM Family of Multi-Application and Multi- |
| Technology Platforms [Soprano XL, Soprano XLi and Soprano ICE] |
Intended Use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano de, Soprano de and Soprano (5) is intended for use in dermatologic and general surgical procedures.
Indications for Use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano ^', Soprano * and Soprano "CE] includes Diode Laser and NIR Modules
Diode Laser Modules:
The indications for use for the 810mm Modified Diode Laser Module 1.2 cm² include:
- The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch (LB) Mode)
. Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR. SHR and LB Modes)
Optional Tapered Light Guide: It is intended for the same use as the device.
The indications for use for the 810nm Modified Diode Laser Module 2 cm² include:
- . The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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 indications for use for the 755nm Diode Laser Module include:
- The Hair Removal (HR) and Super Hair Removal(SHR) Mode is 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.
- The treatment of benign vascular and pigmented lesions.(The Laser Blanch Mode) 트
- Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR and Laser Blanch Modes) .
3
NIR Modules
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, 트
- The temporary relief of minor joint pain associated with arthritis,
- 프 The temporary increase in local circulation where applied, and
- 미 The relaxation of muscles; may also help muscle spasms, minor sprains and minor muscular back pain.
| Prescription Use | ✓ | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (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 BSA
Neil R Ogden -S
2014.08.28 14:45:04 -04'00'
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
4
Section 8 – 510(k) Summary or 510(k) Statement
I. General Information
| Submitter: | Alma Lasers, Ltd,
Halamish St. POB 302
Industrial Park, 38900 |
|---------------------------|---------------------------------------------------------------------|
| Contact Person: | Kathy Maynor
Consultant
352-586-3113 (cell) |
| Summary Preparation Date: | Aug 28, 2014 |
II. Names
| Device Names: | The Modified Alma Lasers Soprano XL™ Family of Multi-
Application and Multi-Technology Platforms [Soprano XL,
Soprano XLi and Soprano ICE] |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Classification Names: | Surgical Powered Light Instrument,
Lamp, Infrared, Therapeutic Heating |
III. Predicate Devices
| K | # | Predicate Device |
|---|---|---|
| K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment | |
| Mode for use with the family of Soprano XL Multi-Application | ||
| Platforms | ||
| K102716 | Modified Alma Lasers Family of Soprano Family XLTM Multi | |
| Application Platform (SopranoXL, SopranoXLi). | ||
| K083848 | Alma Lasers Soprano XL Multi-Application Platform | |
| K080318 | Alma Lasers NIR Module | |
| K090571 | Alma Lasers Alex755 Module | |
| K101916 | Sciton Clear Scan | |
| K083207 | Quanta System Ultrawave III EX 1320 |
IV. Product Description
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano ™ and Soprano "CE] is a modification to previously cleared Soprano Family XL ™M
Multi Application Platform [Soprano **] The relevant K number is K102716
Soprano 40, the new addition to the family has hand pieces with multiple wavelengths, spot sizes and supports both Diode Laser and Near Infrared (NIR) Technologies. The Soprano 40 comprises of the following major components:
5
-
- The main console unit
-
- Footswitch.
-
V. Indications for Use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology
Platforms [Soprano ** and Soprano *** and Soprano *** jis intended for use in dermatolog
The Indications for Use are provided in Section 7 of this submission.
6
VI. Summary of Technical Characteristics
Table 1: Salient Characteristics of the modified diode 810nm module spot size 1.2 cm2 and the Predicate Devices
| | K14
Alma Lasers Modified 810nm Diode
Laser Module to be used with cleared
Soprano XL and XLi Platform and
proposed SopranoICE | K112031
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 | Parameter | K13
Alma Lasers Modified 810nm Diode Laser Module
to be used with cleared Soprano XL and XLi
Platform and proposed Soprano ICE | K112031
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 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Parameter
Product Code &
Regulation No. | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 | Product Code &
Regulation No. | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 | GEX
21 CFR 878.4810 |
| Diode Module
Modes | SHR HR LB | SHR HR LB | HR LB | HR | Diode Module Modes | SHR
HR | SHR HR LB | HR LB | HR |
| Laser Wavelength
[nm] | 810(nominal) | 810(nominal) | 810(nominal) | 810(nominal) | Laser Wavelength [nm] | 810(nominal) | 810(nominal) | 810(nominal) | 810(nominal) |
| Light/Laser
Source | Diode | Diode | Diode | Diode | Light/Laser Source | Diode | Diode | Diode | Diode |
| Spot
Size[mmmm] or
[cm2] | 1210 or 1.2, optional 6mm round
tapered light guide tip | 1210 or 1.2 | 1210 or 1.2 | 12 10 or 1.2 | Spot Size[mmmm] or
[cm2] | 2010 or 2 | 1210 or 1.2 | 1210 or 1.2 | 12* 10 or 1.2 |
| Fluence
(Energy Density)
[J/cm2] | 2-20 | 2-120 Up to 40 | $≤$ 10 $≤$ 120 | $≤$ 80 $≤$ 120 | Fluence
(Energy Density)
[J/cm2] | Up to 20 |