(22 days)
Tattoo Removal
- dark ink: blue and black
- light ink: red
- light ink: sky blue
- light ink: green
Treatment of Vascular Lesions
- port wine birthmarks
- telangiectasias
- spider angioma
- cherry angioma
- spider nevi
Treatment of Pigmented Lesions
- cafe-au-lait birthmarks
- solar lentiginos
- senile lentiginos
- becker's nevi
- freckles
- nevus spilus
- nevus of ota
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Removal or lightening of unwanted hair with or without adjuvant preparation
Medlite C6 Q-Switched Nd:YAG Laser
The provided text is a 510(k) summary for the Medlite C6 Q-Switched Nd:YAG Laser. It explicitly states "Nonclinical Performance Data: None" and "Clinical Performance Data: None". This means there are no acceptance criteria or studies presented within this document to demonstrate the device meets any specific performance metrics.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data are reported.
- Sample sized used for the test set and the data provenance: No test set information is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method for the test set: No test set or adjudication method is described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No such study is mentioned; this device is a laser system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
- The type of ground truth used: No ground truth is mentioned.
- The sample size for the training set: Not applicable for this type of device.
- How the ground truth for the training set was established: Not applicable for this type of device.
Conclusion:
The Medlite C6 Q-Switched Nd:YAG Laser received 510(k) clearance based on its substantial equivalence to predicate devices (Medlite™ IV, Medlite™ C3 Q-Switched Nd:YAG Lasers). The application explicitly states that no nonclinical or clinical performance data was submitted to demonstrate meeting specific acceptance criteria through a study. This implies that its safety and effectiveness were deemed acceptable based on the established performance and regulatory history of the equivalent predicate devices.
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| 510(k) Summary | K014234 | |
|---|---|---|
| Submitter: | Continuum Electro-Optics, Inc.3150 Central expresswaySanta Clara, CA 95051 | JAN 1 7 2002 |
| Contact: | Ronald Kohlhardt | |
| Date Summary Prepared: | December 19, 2001 | |
| Device Trade Name: | Medlite C6 Q-Switched Nd:YAG Laser | |
| Common Name: | Medical Laser System | |
| Classification Name: | Instrument, surgical, powered, laser79-GEX | |
| Equivalent Device(s): | Medlite™ IV Q-Switched Nd:YAG LaserMedlite™ Q-Switched Nd:YAG LaserMedlite™ C3 Q-Switched Nd:YAG Laser | |
| Intended Use: | ● Tattoo Removal● Treatment of Vascular Lesions● Treatment of Pigmented Lesions● Incision, Excision, Ablation, Vaporization of Soft Tissue forGeneral Dermatology● Removal or lightening of unwanted hair with or without adjuvant preparation | |
| Comparison: | The Medlite C6 Q-Switched Nd:YAG Laser bases itsdesign/construction from the integration of primary subsystemsextracted from legally marketed predicate Continuum products. Thenew device performs and is specified within all product parametersof the predicate devices. | |
| Nonclinical Performance Data: | None | |
| Clinical Performance Data: | None | |
| Additional Information: | None |
:
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes. The bird is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2002
Continuum Electro-Optics, Inc. Ronald Kohlhardt Director, Regulatory Compliance and Quality Assurance 3150 Central Expressway Santa Clara, California 95051-0801
Re: K014234
Trade Name: Medlite C6 Q-Switched Nd: YAG Laser Regulation Number: 878.4810 Regulation Name: Laser Surgical Instrument Regulatory Class: II Product Code: GEX Dated: December 19, 2001 Received: December 26, 2001
Dear Mr. Kohlhardt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 - Mr. Ronald Kohlhardt
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin manisting of substantial equivalence of your device to a legally premarket notification: "The Privating sification 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 and If you desire specific acriso to: you in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 607.10 Idditionally, for questions on the promotion and advertising of Compilance at (301) 597-1637. Freeded Compliance at (301) 594-4639. Also, please note the your do roo, pread o concerner to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general information on your new 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/dsma/dsmamain.html
Sincerely yours,
Mark N. Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K014234
Device Name:
Medlite C6 Q-Switched Nd: YAG Laser.
Indications for Use:
Tattoo Removal
- dark ink: blue and black ●
- light ink: red .
- light ink: sky blue .
- light ink: green .
Treatment of Vascular Lesions
- port wine birthmarks .
- telangiectasias ●
- spider angioma ●
- cherry angioma .
- spider nevi ●
Treatment of Pigmented Lesions
- cafe-au-lait birthmarks .
- solar lentiginos .
- senile lentiginos �
- becker's nevi .
- freckles .
- nevus spilus .
- nevus of ota
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Removal or lightening of unwanted hair with or without adjuvant preparation
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark N Miller
Divisio Sign-Cim i islop of General. Restorative and Neuronogical Devices
K014234 210(k) Number_
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
§ 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.