(41 days)
Not Found
No
The summary describes a laser hair removal system with standard components and does not mention any AI or ML capabilities.
No
The device is intended for hair removal and permanent hair reduction, which are considered cosmetic procedures, not therapeutic treatment of a disease or medical condition.
No
The document states the device is intended for hair removal and permanent hair reduction, which are therapeutic purposes, not diagnostic.
No
The device description explicitly lists multiple hardware components, including a console unit, handpiece, and footswitch, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hair removal and permanent hair reduction." This is a cosmetic or therapeutic procedure performed directly on the patient's body.
- Device Description: The components described (laser, handpiece, cooling system) are consistent with a device that interacts directly with the patient's tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition or provide information about a physiological state.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SOPRANO™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The SOPRANO™ System is indicated for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Product codes
GEX
Device Description
The modified MSq SOPRANO™ Hair Removal Diode Laser System is comprised of the following components:
- Console Unit that includes the main CPU Board, Power Supply Units, . Control Panel, Service Panel, Cooling System, Keyswitch, Emergency Stop, and Isolating Transformer;
- Handpiece (with Connector) that includes Optical Head, Tissue Cooling . system (the cold plate) and Handpiece Trigger;
- Footswitch. .
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)
Reference Device(s)
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
ATTACHMENT 8 - 510(K) SUMMARY I.
Confidential
-
- General Information
Submitter:
- General Information
Contact Person:
MSq. (M2) Ltd. 7 Haeshel Street (P.O.Box 3021) Caesarea Industrial Park Caesarea 38900. Israel Tatiana Epstein Regulatory Affairs Manager
Summary Preparation Date:
- Names
Device Names:
SOPRANO™ Hair Removal Diode Laser System
Primary Classification Name:
Surgical Powered Laser Instrument
3. Predicate Device
- MSq MYTHOSTM Hair Removal Diode Laser System (K030805) .
October 23, 2005
4. Product Description
The modified MSq SOPRANO™ Hair Removal Diode Laser System is comprised of the following components:
- Console Unit that includes the main CPU Board, Power Supply Units, . Control Panel, Service Panel, Cooling System, Keyswitch, Emergency Stop, and Isolating Transformer;
- Handpiece (with Connector) that includes Optical Head, Tissue Cooling . system (the cold plate) and Handpiece Trigger;
- Footswitch. .
5. Indications for Use
The SOPRANO™ Hair Removal Diode Laser is intended for hair removal and permanent hair reduction. The SOPRANO™ System is indicated for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
1
6. Rationale for Substantial Equivalence
The modified MSq SOPRANO™ Hair Removal Diode Laser System shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate MSq MYTHOS™ Hair Removal Diode Laser System (K030805).
7. Safety and Effectiveness Information
The review of the indications for use, technical characteristics, risk analyses, and verification and validation information provided demonstrate that the modified MSq SOPRANO™ Hair Removal Diode Laser System is substantially equivalent to the predicate device.
8. Conclusion
The modified MSq SOPRANO™ Hair Removal Diode Laser System was found to be substantially equivalent to the predicate MSq MYTHOS™ Hair Removal Diode Laser System (K030805).
The modified MSq SOPRANO™ Hair Removal Diode Laser System shares identical indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS) in the United States. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
NOV 2 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Tatiana Epstein Regulatory Affairs Manager MSq. (M2) Ltd. 7 Haeshel Street (P.O. Box 3021) Caesarea Industrial Park Caesarea 38900, Israel
Re: K052874
Trade/Device Name: SOPRANO™ Hair Removal Diode Laser System 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: October 26, 2005
Received: October 28, 2005
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 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.
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Page 2-Tatiana Epstein
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Barbara Buckland
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 2 - INDICATIONS FOR USE STATEMENT AS C. REQUESTED BY FDA
510(k) Number (if known)
K 052874
Device Name SOPRANO™ Hair Removal Diode Laser System
The SOPRANO™ Hair Removal Diode Laser is intended for hair Indications for Use removal and permanent hair reduction. The SOPRANO™ System is indicated for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801. 109)
OR Over-The-Counter Use
Carlaue Buchem
Sign-Off Division of General, Restorative, and Neurological Devices
Special 510 (k) Submission for SOPRANO™
Attachment 2 - Page C-1
510(k) Number K052874