The BClear™, Targeted PhotoClearing™ System, is a medical ultraviolet lamp and delivery device intended for the treatment of leukoderma. The BClear, Targeted PhotoClearing System, is also indicated 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 unnecessary exposure to non-affected 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 document is a 510(k) summary for the BClear, Targeted PhotoClearing System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study details is explicitly not applicable or not provided in this specific document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria	Reported Device Performance
Safety	Not explicitly stated, but implied to be equivalent to predicate devices.	"The technological specifications of the BClear, Targeted PhotoClearing System, are the same or very similar to those of the claimed predicate devices." No adverse events or safety concerns are raised.
Effectiveness	Not explicitly stated, but implied to be equivalent to predicate devices for the specified indications.	"The BClear, Targeted PhotoClearing System, has the same indications for use for which the claimed predicates have been cleared." No specific performance metrics (e.g., clearance rates, time to response) are provided.
Indications for Use	"Intended for the treatment of leukoderma. ... also indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. ... intended for use on all skin types (I - VI)."	The document states in its "Substantial Equivalence" section: "The BClear, Targeted PhotoClearing System, has the same indications for use for which the claimed predicates have been cleared." This implies it meets the same intended use as the predicate devices.
Technological Characteristics	Not explicitly stated, but the expectation is for the BClear system to be similar or identical to the predicate devices.	"The technological specifications of the BClear, Targeted PhotoClearing System, are the same or very similar to those of the claimed predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. The document explicitly states: "Performance Data: 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."
Data Provenance: Not applicable, as no new performance data was generated for this 510(k) submission. The decision is based on substantial equivalence to previously cleared predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no new performance study with a test set was conducted.

4. Adjudication Method for the Test Set

Not applicable, as no new performance study with a test set was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. The document explicitly states "Performance Data: None."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

No. This device is a physical medical ultraviolet lamp and delivery system, not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant. The substantial equivalence argument is based on the device's physical and functional similarity to predicate devices.

7. The Type of Ground Truth Used

Not applicable, as no new performance study was conducted. The "ground truth" for the device's safety and effectiveness relies on the prior clearance and established use of the predicate devices for their indicated conditions. The document mentions "Currently published clinical data supports UVB treatment of hypopigmented or depigmented skin (leukoderma)," which indirectly points to existing clinical evidence for the treatment modality, but not for this specific device's new performance evaluation.

8. The Sample Size for the Training Set

Not applicable, as this device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as this device is not an AI/ML algorithm that requires a training set.

Summary of the Study Proving Acceptance Criteria:

The "study" in this case is not a clinical trial or performance study of the BClear device itself. Instead, the document describes a substantial equivalence claim based on a comparison to legally marketed predicate devices:

Predicate Devices: Lumenis Inc., BClear, Targeted PhotoClearing System (K011197, K020591); PhotoMedex, XTRACTM Excimer Laser Phototherapy System, AL7000 (K011382, K992914, K003705).
Argument: The applicant argues that the BClear, Targeted PhotoClearing System, is substantially equivalent because:
- Its technological specifications are the same or very similar to those of the claimed predicate devices. (This implies that the underlying technology for delivering UV-B light to treat dermatological conditions is consistent with established and cleared devices).
- It has the same indications for use as the cleared predicate devices (treatment of leukoderma, psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis, for all skin types I-VI).
Basis for No Performance Data: Because of this perceived substantial equivalence in both technology and indications for use, the submission explicitly states that "performance data is not required." The assumption is that since the device is essentially the same as (or very similar to) a device already on the market and cleared for the same purposes, its performance will be comparable.

Therefore, the "study" proving the device meets acceptance criteria is fundamentally a comparative analysis of device characteristics and intended use against already cleared predicate devices, rather than a de novo performance evaluation.

Summary

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021762 1/2

AUG 2 3 2002

510(k) Summary of Safety and Effectiveness

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:	(925) 249-8031
Fax:	(925) 249-8010
Preparation Date:	May 24, 2002
Device Trade Name:	BClearTM
Common Name:	Localized, narrow band ultraviolet phototherapyequipment
Classification Name:	Ultraviolet lamp for dermatologic/skin disorders(see 21 CFR 878.4630).
Legally Marketed Predicate Devices:	Lumenis Inc.,BClear, Targeted PhotoClearing System(K011197, K020591);PhotoMedex, the parent of AccuLase, Inc.,XTRACTM Excimer Laser PhototherapySystem, AL7000(K011382, K992914, K003705).
System Description:	The BClear, Targeted PhotoClearing System, isan ultraviolet light source and energy deliverysystem that provides targeted energy to thetreatment site while avoiding unnecessaryexposure to non-affected tissue.The lightsource is contained within a protective console.The complete system also includes a handpiececonnected to the console via an umbilical.Timing and dosing parameters and an interfaceto other system features are controlled from adisplay panel on the console. The delivery

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K021762

system allows UV-B light to pass through the handpiece to selectively treat skin and nail lesions without exposure to the healthy skin.

2/2

The BClear, Targeted PhotoClearing System, is a medical ultraviolet lamp and delivery device intended for the treatment of leukoderma. The BClear, Targeted PhotoClearing System, is also indicated 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 hypopigmented or depigmented skin (loukoderma). The intended use of the BClear, Targeted PhotoClearing System, is within the scope of the predicate devices. The BClear and predicate devices use UV-B phototherapy for the treatment of dermatoses.

The BClear, Targeted PhotoClearing System, is currently indicated for treatment of psoriasis, vitiligo. atopic dermatitis (eczema) and seborrheic dermatitis in 510(k)s K011197 and K020591.

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 seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lumenis, Inc. C. Robert Payne, Jr., P.E. Director of Regulatory Affairs and Quality Assurance 1249 Ouarry Lane, Suite 100 Pleasanton, California 94566

Re: K021762

Trade/Device Name: BClear™ Regulation Number: 878.4630 Regulation Name: Ultraviolet lamp for dermatologic/skin disorders Regulatory Class: Class II Product Code: FTC Dated: May 24, 2002 Received: May 29, 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 setforth 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.

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" (21 CFR 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.

Sincerely yours,

Mark A Millman
Celia M. Witten, Ph.D., M.D.

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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INDICATIONS FOR USE STATEMENT

K021762 510(k) Number:

BClear™ Devicc 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

Mark N. Melleuson

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

510(k) Number K021762

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.