(77 days)
The Cheveux Diode Laser System is indicated for: Hair Removal Permanent hair reduction Treatment of vascular lesions Treatment of benign pigmented lesions Treatment of Leg Veins Treatment for pseudofolliculitis barbae The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin
The Cheveux Diode Laser System delivers laser light with an 810 nm wavelength. The system consists of a console and a handpiece connected to the system by an umbilical. Energy output is initiated with trigger on the handpiece.
The Cheneux Diode Laser System's 510(k) summary does not contain the level of detail requested for acceptance criteria and study design. The document is a regulatory submission for substantial equivalence to a predicate device, not a detailed report of clinical performance.
Here's a breakdown of what can be extracted and what is explicitly missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given document. The 510(k) summary states, "The Cheveux Diode Laser System is substantially equivalent to other existing diode laser systems in commercial distribution for use in Dermatology and Plastic Surgery." This is a regulatory conclusion, not a presentation of performance data against specific acceptance criteria.
The document lists "Performance Data" but then only states "Results of Clinical Study: The Cheveux Diode Laser System is substantially equivalent to other existing diode laser systems in commercial distribution for use in Dermatology and Plastic Surgery." This confirms the lack of specific performance metrics or acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. No specific clinical trial details are given, therefore no sample size for a test set or data provenance (country, retrospective/prospective) can be determined.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. Since no specific clinical trial data or ground truth establishment is described, neither the number nor the qualifications of experts are mentioned.
4. Adjudication Method
This information is not provided in the document. No adjudication method is mentioned as there is no detailed description of a clinical study or ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided in the document. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device is a laser system, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance
This information is not applicable and not provided. The Cheveux Diode Laser System is a physical medical device (a laser system), not an algorithm or AI system for which "standalone performance" would be relevant in the way you've described.
7. Type of Ground Truth Used
This information is not provided in the document. There is no mention of any ground truth (expert consensus, pathology, outcomes data) being established for a clinical study related to this device.
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a laser system, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided. As above, this is a physical device, not an AI algorithm.
In summary, the provided 510(k) summary for the Cheveux Diode Laser System focuses on demonstrating substantial equivalence to a predicate device (LightSheer Diode Laser System K003614) based on its technological characteristics and intended use. It does not include the detailed performance data, acceptance criteria, or study design information typically found in a clinical trial report for new technology or AI diagnostics. The "Performance Data" section explicitly states the conclusion of substantial equivalence rather than presenting specific quantitative performance results against criteria.
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Attachment 5 510(K) Summary Cheveux Diode Laser System
JUN 1 6 2010 -
K 100893
This 510(K) Summary of safety and effectiveness for the Cheveux Diode Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance conceming the organization and content of a 510(K) summary.
Mr. Mark Rohrer
1-205-356-1172 ssmed@bellsouth.net
April 1, 2010
Diode Laser
Leg Veins
None
None
Sandstone Medical Technologies, LLC Applicant:
Address:
Sandstone Medical Technologies LLC 105 Citation Court Birmingham, AL 35209
Cheveux Diode Laser System
79-GEX, 21 CFR 878-48
Instrument, Surgical, Powered, laser
LightSheer Diode Laser System K003614
Contact Person:
Telephone:
Preparation Date:
Device Trade Name:
Common Name:
Classification Name:
Legally Marketed Predicate Device(s):
Description of the Cheveux Diode Laser System
Intended use of the Cheveux Diode Laser System
Performance Data:
Results of Clinical Study:
Conclusion:
The Cheveux Diode Laser System is substantially equivalent to other existing diode laser systems in commercial distribution for use in Dermatology and Plastic Surgery.
The Cheveux Diode Laser System delivers laser light with an
The Cheveux Diode Laser System is intended to be used for
Hair Removal, Permanent hair reduction, Treatment for pseudofolliculitis barbae, Treatment of vascular lesions, Treatment of benign pigmented lesions, and Treatment of
810 nm wavelength. The system consists of a console and a handpiece connected to the system by an umbilical. Energy output is initiated with trigger on the handpiece.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sandstone Medical Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Homewood, Alabama 35209
JUN 1 6 2010
Re: K100893
Trade/Device Name: Cheveux 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: Class II Product Code: GEX Dated: March 31. 2010
Received: April 01, 2010
Dear Mr. Rohrer:
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
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Page 2 - Mr. Mark Rohrer
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 (OS) 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.htm 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/ResourcesforYou/Industry/default.htm.
Sincerely vo
N. Melkerson
Mark Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
ুটি
Cheveux Diode Laser System
The Cheveux Diode Laser System is indicated for: Hair Removal Permanent hair reduction Treatment of vascular lesions Treatment of benign pigmented lesions Treatment of Leg Veins Treatment for pseudofolliculitis barbae
The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin
Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices Page 1 of 1
| 510(k) Number | K100893 |
|---|---|
| --------------- | --------- |
§ 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.