BCLEAR by LUMENIS | FDA 510(k) Summary

The BClear™, Targeted PhotoClearing System, is a medical ultraviolet lamp and delivery device that is intended for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema) and seborrheic dermatitis. The BClear, Targeted PhotoClearing System, is intended for use on all skin types (I — VI).

Device Description

The BClear, Targeted PhotoClearing System, is an ultraviolet light source and energy delivery system that provides targeted energy to the treatment site while avoiding exposure to nonaffected tissue. The light source is contained within a protective console. The complete system also includes a handpiece connected to the console via an umbilical. Timing and dosing parameters and an interface to other system features are controlled from a display panel on the console. The delivery system allows UV-B light to pass through the handpiece to selectively treat skin and nail lesions without exposure to the healthy skin.

AI/ML Overview

The provided 510(k) summary for the BClear™ Targeted PhotoClearing System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, the submission relies on demonstrating substantial equivalence to legally marketed predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as existing devices already cleared by the FDA, based on similar intended use and technological specifications.

Therefore, many of the requested details, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies, are not applicable in this specific 510(k) submission.

Here's a breakdown of what can be extracted from the provided text based on your prompt:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not applicable. The submission relies on substantial equivalence to predicate devices, not on meeting specific performance criteria demonstrated by a new study.	Not applicable. No specific performance metrics are reported as the basis for clearance. The device is claimed to have "the same or very similar" technological specifications to predicate devices.

2. Sample size used for the test set and the data provenance: Not applicable. No new performance study evaluating the device against a test set was conducted or reported in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new performance study requiring expert ground truth for a test set was conducted.

4. Adjudication method for the test set: Not applicable.

5. 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: Not applicable. This device is a UV phototherapy system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a phototherapy system, not an algorithm.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. No new development of an algorithm or model requiring a training set is described.

9. How the ground truth for the training set was established: Not applicable.

Explanation from the document:

The key section regarding performance data states:

"None. The technological specifications of the BClear, Targeted PhotoClearing System, are the same or very similar to those of the claimed predicate devices. The BClear, Targeted PhotoClearing System, has the same indications for use for which the claimed predicates have been cleared. Therefore, [new] performance data is not required."

And in the Conclusion:

"Based on the foregoing, the BClear, Targeted PhotoClearing System, is substantially equivalent to the legally marketed, claimed predicate devices for the purposes of this 510(k) submission."

This indicates that the FDA clearance for this device was based on demonstrating its similarity to devices already on the market, rather than submitting new clinical performance data with specific acceptance criteria.

Summary

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020591

510(k) Summary of Safety and Effectiveness

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This 510(k) Summary of Safety and Effectiveness for the BClear™, Targeted PhotoClearing System, is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE) guidance concerning the organization and content of a 510(k) summary.

Applicant:	Lumenis Inc.
Address:	1249 Quarry Lane, Suite 100Pleasanton, CA 94566
Contact Person:	C. Robert Payne, Jr., P.E.
Telephone:Fax:	(925) 249-8031(925) 249-8010
Preparation Date:	February 27, 2002
Device Trade Name:	BClear™
Common Name:	Localized, narrow band ultraviolet phototherapyequipment
Classification Name:	Ultraviolet lamp for dermatologic/skin disorders(see 21 CFR 878.4630).
Legally Marketed Predicate Devices:

PhotoMedex, the parent of AccuLase, Inc., XTRAC™ Excimer Laser Phototherapy System, AL7000 (K011382; K992914, K003705); Daavlin Co., Psorawand™ (Psoralite; K930856).

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020591 2/2

System Description:

The BClear, Targeted PhotoClearing System, is a medical ultraviolet light source and delivery device intended for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema) and seborrheic dermatitis. The BClear, Targeted PhotoClearing System, is intended for use on all skin types (I -VI).

Currently published clinical data supports UVB treatment of atopic dermatitis (eczema) and seborrheic dermatitis. The intended use of the BClear, Targeted PhotoClearing System, is within the scope of the predicate devices.

The BClear, Targeted PhotoClearing System, is currently indicated for treatment of psoriasis and vitiligo in 510(k) K011197.

None. The technological specifications of the BClear, Targeted PhotoClearing System, are the same or very similar to those of the claimed predicate devices. The BClear, Targeted PhotoClearing System, has the same indications for use for which the claimed predicates have been cleared. Therefore, performance data is not required.

Based on the foregoing, the BClear, Targeted PhotoClearing System, is substantially equivalent to the legally marketed, claimed predicate devices for the purposes of this 510(k) submission.

Intended Use of the Device:

Substantial Equivalence:

Performance Data:

Conclusion:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 with three curved lines representing its wings or feathers. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The text is in all capital letters and is evenly spaced to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2002

Mr. C. Robert Payne, Jr., P.E. Director of Regulatory Affairs/Quality Assurance Lumenis, Inc. 1249 Quarry Lane, Suite100 Pleasanton, CA 94566

Re: K020591

Trade/Device Name: BClear™ Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: February 20, 2002 Received: February 22, 2002

Dear Mr. Payne:

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 - Mr. C. Robert Payne, Jr., P.E.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

for 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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INDICATION FOR USE STATEMENT

510(k) Number: K020591 BClear™ Device Name:

Indications for Use:

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR (per 21 CFR 801.109) Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Miriam C. Provost

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K 020591

Regulation Number and Section

§ 878.4630 Ultraviolet lamp for dermatologic disorders.

(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.