(83 days)
No
The summary describes a UV light delivery system with manual controls for timing and dosing, and there is no mention of AI, ML, or any features that would suggest automated decision-making or learning from data.
Yes
The device is intended for the treatment of various skin conditions like psoriasis, vitiligo, atopic dermatitis, and seborrheic dermatitis, which indicates a therapeutic purpose.
No
The device description indicates it is a "treatment" system that provides "targeted energy" and "UV-B light" to treat skin and nail lesions. There is no mention of the device being used to diagnose conditions or process diagnostic information.
No
The device description explicitly states it is an "ultraviolet light source and energy delivery system" that includes a "protective console" and a "handpiece connected to the console via an umbilical." These are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "medical ultraviolet lamp and delivery device that is intended for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema) and seborrheic dermatitis." This describes a therapeutic device that applies energy to the body for treatment.
- Device Description: The description reinforces this by detailing an "ultraviolet light source and energy delivery system" that provides "targeted energy to the treatment site."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used to directly treat conditions on the skin.
N/A
Intended Use / Indications for Use
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).
Product codes
FTC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and nail lesions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Performance data is not required.
Key Metrics
Not Found
Predicate Device(s)
K011382, K992914, K003705, K930856
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
020591
510(k) Summary of Safety and Effectiveness
1/2
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 |
| Pleasanton, 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 phototherapy |
| equipment | |
| 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).
20
1
020591 2/2
System 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.
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:
2
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.
3
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
4
INDICATION FOR USE STATEMENT
510(k) Number: K020591 BClear™ Device Name:
Indications for Use:
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).
(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