BCLEAR

K021762 · Lumenis, Inc. · FTC · Aug 23, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021762
• Device Name: BCLEAR
• Applicant: Lumenis, Inc.
• Product Code: FTC · General, Plastic Surgery
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

BClear Targeted PhotoClearing System is an ultraviolet (UV) light source and delivery system for targeted phototherapy. Device consists of a protective console containing the UV light source and a handpiece connected via an umbilical. Operator controls timing and dosing parameters via a console display panel. System delivers UV-B light through the handpiece to selectively treat skin and nail lesions while sparing healthy tissue. Intended for clinical use to treat dermatoses; benefits include localized treatment of affected areas. No patient-specific data input or automated analysis described.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological similarity to legally marketed predicate devices.

Technological Characteristics

Ultraviolet lamp for dermatologic/skin disorders (21 CFR 878.4630). System comprises a protective console housing the UV light source and a handpiece for energy delivery via an umbilical. Provides targeted UV-B phototherapy. Class II device.

Indications for Use

Indicated for treatment of leukoderma, psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis in patients of all skin types (I-VI).

Regulatory Classification

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.

Predicate Devices

• BClear, Targeted PhotoClearing System (K011197, K020591)
• XTRACTM Excimer Laser Phototherapy System, AL7000 (K011382, K992914, K003705)

Submission Summary (Full Text)

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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 100<br>Pleasanton, CA 94566 |
| Contact Person: | C. Robert Payne, Jr., P.E. |
| Telephone: | [phone] |
| Fax: | [phone] |
| Preparation Date: | May 24, 2002 |
| Device Trade Name: | BClearTM |
| Common Name: | Localized, narrow band ultraviolet phototherapy<br>equipment |
| Classification Name: | Ultraviolet lamp for dermatologic/skin disorders<br>(see 21 CFR 878.4630). |
| Legally Marketed Predicate Devices: | Lumenis Inc.,<br>BClear, Targeted PhotoClearing System<br>(K011197, K020591);<br>PhotoMedex, the parent of AccuLase, Inc.,<br>XTRACTM Excimer Laser Phototherapy<br>System, AL7000<br>(K011382, K992914, K003705). |
| System Description: | The BClear, Targeted PhotoClearing System, is<br>an ultraviolet light source and energy delivery<br>system that provides targeted energy to the<br>treatment site while avoiding unnecessary<br>exposure to non-affected tissue.<br>The light<br>source is contained within a protective console.<br>The complete system also includes a handpiece<br>connected to the console via an umbilical.<br>Timing and dosing parameters and an interface<br>to other system features are controlled from a<br>display 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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:

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).

(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