The PlasmaLuxLS is a medical light source, which is intended for use for the treatment of moderate acne vulgaris with blue light.
The PlasmaLuxLS is a medical laser device, which is intended for the treatment of moderate inflammatory acne vulgaris.

Device Description

The PlasmaLuxLS is a compact light source that delivers a uniform distribution of light, with spectral output at peak wavelengths of 417 nm (Blue Light) a It is intended for use by or under the direction of a physician for the treatment of moderate acne vulgaris with blue light. The desired dose is selected using the operator interface located on the front panel of the device. The PlasmaLux LS device delivers local area phototherapy, whereby lamps deliver the specified dose of Blue Light.

AI/ML Overview

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

This 510(k) summary does not contain any information about acceptance criteria or specific studies to prove device performance.

The document explicitly states under the "Performance Data" section: "No Data Provided."

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer is asserting that their device is as safe and effective as existing, approved devices because it has a similar design, operates on the same principles, and is intended for the same use.

Therefore, since no performance data was provided, it's impossible to fill out a table of acceptance criteria or describe a study proving the device meets them.

However, I can extract the other requested information based on the premise that a study would exist, though none is present in this 510(k) summary.

Summary of Acceptance Criteria and Device Performance (Not Applicable - No Data Provided)

Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Safety endpoints)	Reported Device Performance	Met/Not Met
No data provided in this 510(k) summary.	No data provided.	N/A

Since no performance data was provided, the following sections will indicate "Not Applicable" or "No information provided" as the relevant details are missing from the given document.

Detailed Information about the Study (Not Applicable - No Study Data Provided)

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): No information provided.
- Data Provenance: No information provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- No information provided.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No information provided.
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 information provided. (The device is a light therapy device, not an AI-assisted diagnostic tool, so an MRMC study in this context is unlikely).
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- No information provided. (The device is a light therapy device, not an algorithm, so this concept does not apply).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- No information provided.
The sample size for the training set:
- No information provided.
How the ground truth for the training set was established:
- No information provided.

Reasoning for "No Data Provided"

The Daavlin Distributing Company's 510(k) submission for the PlasmaLuxLS relies on demonstrating substantial equivalence to predicate devices rather than providing new performance data from clinical studies for this specific device. They state:

"The PlasmaLuxLS is constructed in the same design configuration as the predicate devices, utilizing similar energy types and materials of identical composition."
"The light emitted by the PlasmaLux is of identical spectrum and power as that of the predicate devices."
"The PlasmaLux can be used with exactly the same treatment regimes as the predicate devices."

This approach is common for devices that are very similar to already approved ones, where the FDA determines that new clinical performance data is not necessary to establish safety and effectiveness. The "Performance Data: No Data Provided" explicitly indicates that the manufacturer did not submit specific studies for this device.

Summary

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K100628 pg. 1 of 2

NOV 2 4 2010

510(k) Summary

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The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

Submitter's Name:	The Daavlin Distributing Company
Registration Number:	1526255
Address:	205 West Bement StreetBryan, Ohio 43506
Telephone:	419.636.6304
Contact:	Michele Thiel
Date Prepared:	March 2, 2010
Device Trade Name:	PlasmaLuxLS
Device Common Name:	Light Therapy Device
Device Classification:	Class II
Product Code:	ONE
Regulation Number:	CFR 878.4810, 890.5500
Regulation Name:	Laser surgical instrument for use in General and Plastic surgeryand in Dermatology.
Predicate Devices:	DUSA Pharmaceuticals, Inc.
	BLU-U Blue Light Photodynamic Therapy Illuminator Model4170K031805

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K100628

f 2 of 2

Lynton Lasers Limited Light Source K062871

LumaCare LC-122-M Non-coherent

LIGHTWAVE Technologies LLC Lightwave Professional Deluxe K083586

Device Description:

Predicate Device Comparison:

The PlasmaLuxLS is constructed in the same design configuration as the predicate devices, utilizing similar energy types and materials of identical composition. The light emitted by the PlasmaLux is of identical spectrum and power as that of the predicate devices. The PlasmaLux can be used with exactly the same treatment regimes as the predicate devices.

Intended Use:

The PlasmaLuxLS is a medical light source, which is intended for use for the treatment of moderate acne vulgaris with blue light.

Performance Data:

No Data Provided.

Conclusion:

On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the PlasmaLuxLS is substantially equivalent to the legally commercialized predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

The Daavlin Distributing Company % Ms. Michele Thiel 205 West Bement Street Bryan, Ohio 43506

Re: K100628

Trade/Device Name: PlasmaLuxLS 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: ONE Dated: October 26, 2010 Received: - November 03, 2010

Dear Ms. Thiel:

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

NOV 2 4 2010

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Page 2 – Ms. Michele Thiel

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 (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.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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm.

Sincerely yours,

Mark N. Milkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K100628 Pg 1 of 1

Indication for Use

NOV 2 4 2010

510(k) Number

Device Name PlasmaLuxLS

Indications for Use

The PlasmaLuxLS is a medical laser device, which is intended for the treatment of moderate inflammatory acne vulgaris.

Prescription Use - X

Over-the-Counter Use _

(per 21 CFR 801.109)

(Please do not write below this line - Continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mich A. Milkeron

(Division Sign-Oft) Division . surgical, Orthopedic, and Restorative Devices

510(k) Number

Regulation Number and Section

§ 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.