(145 days)
K0138257
Not Found
No
The document does not mention AI, ML, or related terms, and the device description focuses on hardware components and basic software control.
Yes
The device is indicated for the "treatment" of Atrophic Acne Scars, which is a therapeutic purpose.
No.
The device is indicated for treatment and does not mention diagnosis or diagnostic capabilities.
No
The device description clearly lists multiple hardware components, including a laser system console, control and display panel, handpiece, skin cooling device, and safety interlock system. While it mentions software within the console, it is not a software-only device.
Based on the provided information, the Candela Smoothbeam Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of Atrophic Acne Scars." This is a therapeutic use, directly treating a medical condition on a patient's body.
- Device Description: The description details a laser system, handpiece, cooling device, and control systems. These are all components of a device used for direct treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to deliver laser energy to the skin for therapeutic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Candela Smoothbeam Laser System does not fit this description.
N/A
Intended Use / Indications for Use
The Smoothbeam Laser System is indicated for the treatment of Atrophic Acne Scars.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Smoothbeam Laser is comprised of the following main components:
- a laser system console (including software and control electronics)
- a control and display panel
- a fiberoptic-coupled handpiece
- a skin cooling device integrated into the laser (cryogen is delivered via a hose to a nozzle in the handpiece)
- a safety interlock system
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical study was performed that produced results that indicate that the Smoothbeam Laser System is effective for the treatment of Atrophic Acne Scars. No new safety issues were raised in the study of the Smoothbeam Laser.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K0138257
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
KO 22884 1/2
Image /page/0/Picture/1 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black on the left side and has horizontal lines on the right side.
JAN 2 2 2003
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510 (k) Summary of Safety and Effectiveness for the Candela Smoothbeam Laser System is being submitted in accordance with the requirements of the SMDA 1990, 21 CFR 807.92 and follows the guidance concerning the organization and content of a 510 (k) summary.
I. General Information
| Applicant: | Candela Corporation |
|---|---|
| Address: | 530 Boston Post Road |
| Wayland, MA 01778-1886 | |
| Contact Person: | Lorraine Nelson |
| Manager, Regulatory Affairs | |
| Date Prepared: | August 14, 2002 |
| II. Name | |
| Device Trade Name: | Smoothbeam Laser System |
| Device Common Name: | Dermatology Laser |
| Classification: | Class II |
| Product Code- GEX | |
| III. Predicate Device | Candela Smoothbeam Laser (K0138257) |
IV. Product Description
The Smoothbeam Laser is comprised of the following main components:
- a laser system console (including software and control electronics) ●
- a control and display panel
- a fiberoptic-coupled handpiece
- a skin cooling device integrated into the laser (cryogen is delivered ● via a hose to a nozzle in the handpiece)
- a safety interlock system
V. Intended Use
The Smoothbeam Laser System is indicated for the treatment of Atrophic Acne Scars.
1
Image /page/1/Picture/0 description: The image shows a handwritten string of characters, which appears to be a combination of letters and numbers. The string reads 'k022 819'. The characters are written in a cursive style, with varying stroke thicknesses.
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
VI. Rationale For Substantial Equivalence
The Candela Smoothbeam Laser System utilizes similar operating principles and matches key design aspects, including spot size, similar wavelength and/or the same maximum delivered power as the predicate device, and therefore is substantially equivalent to the currently marketed Candela Smoothbeam Laser System (K013825).
VII. Safety and Effectiveness Data
A clinical study was performed that produced results that indicate that the Smoothbeam Laser System is effective for the treatment of Atrophic Acne Scars. No new safety issues were raised in the study of the Smoothbeam Laser.
VIII. Conclusion
The Smoothbeam Laser is effective for the treatment of Atrophic Acne Scars.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The image is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2003
Ms. Lorraine Nelson Manager, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, Massachusetts 01778
Re: K022884
Trade/Device Name: Candela Corporation Smoothbeam Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: November 11, 2002 Received: November 12, 2002
Dear Ms. Nelson:
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 - Ms. Lorraine Nelson
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), 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) you may obtain. 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
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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Image /page/4/Picture/0 description: The image shows the logo for Candela. The logo consists of a stylized flame on the left and the word "CANDELA" on the right. The flame is black and white and has a geometric design. The word "CANDELA" is in a simple, sans-serif font.
INDICATION FOR USE STATEMENT
510(k) Number (if known): KO2Z JPY 4
Device Name:
Candela Corporation Smoothbeam Laser System
Indications For Use:
The Candela Smoothbeam Laser System is indicated for the treatment of Atrophic Acne Scars.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
Muriam C. Provost
( vision Sign-Off) Division of General, Restorative and Neurological Devices
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