(88 days)
Not Found
No
The description focuses on the laser technology, cooling mechanism, and embedded processor for control, with no mention of AI or ML capabilities.
Yes
The device is indicated for use in dermatology for various soft tissue treatments and the treatment of periorbital wrinkles, implying a therapeutic purpose.
No
The device is a therapeutic laser system used for dermatological treatments and does not perform diagnostic functions. It is used to incise, excise, ablate, and vaporize soft tissue, and treat periorbital wrinkles.
No
The device description clearly outlines hardware components including a power supply, optical delivery system, handpiece, and Dynamic Cooling Device, in addition to the software control system.
Based on the provided information, the Candela Smoothbeam Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Candela Smoothbeam Laser System is a medical device that uses a laser to directly treat soft tissue and periorbital wrinkles on the patient's body. It is an in vivo treatment device, not a diagnostic test performed on samples outside the body.
- Intended Use: The intended use clearly states "for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles." This describes a therapeutic procedure performed directly on the patient.
- Device Description: The description details a laser system that delivers energy to the skin via a handpiece and includes a cooling device. This aligns with a treatment device, not a diagnostic one.
Therefore, the Candela Smoothbeam Laser System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Smoothbeam Laser System is indicated for the treatment of periorbital wrinkles.
The Candela Smoothbeam Laser System is indicated for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles.
The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of periorbital wrinkles. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.
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)
Clinical trials produced results that the Smoothbeam Laser System is effective in the treatment of periorbital wrinkles.
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.
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.
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Image /page/0/Picture/1 description: The image shows the date February 15, 2002. The month is represented by the abbreviation FEB. The day is represented by the number 15. The year is represented by the number 2002.
ANDELA
General Information: This 510(k) is to provide notification of su
General Information: This 510(k) is to provide notification of substantial equivalence for the Candela Smoothbeam Laser System, which is substantially equivalent to a previously marketed device intended for use in the treatment of periorbital wrinkles.
| Submitted by: | Candela Corporation |
|---|---|
| Address: | 530 Boston Post Road |
| Wayland, MA 01778-1886 | |
| Contact Person: | Lorraine Nelson |
| Manager, Regulatory Affairs | |
| Date Prepared: | November 16, 2001 |
| Device Trade Name: | Smoothbeam Laser System |
| Device Common Name: | Dermatology Laser |
| Classification: | Class II (21 CFR § 878.4810 Laser Surgical Instrument for use in General |
| and Plastic Surgery and in Dermatology) | |
| Predicate Devices: | Laser Aesthetics CoolTouch (K003715) and Candela 1450 nm Diode laser |
| (K002421) |
Description of the Smoothbeam Laser System: The Diode laser is a Continuous Wave, diode medical laser, controlled by an embedded processor, for use in dermatology for the treatment of periorbital wrinkles. The Candela Smoothbeam Laser System is comprised of a power supply, optical delivery system, software control system and Dynamic Cooling Device. The laser output energy is delivered via an optical fiber to a handpiece, which produces circular beams on the skin. The Dynamic Cooling Device provides a short burst of cryogen spray during the laser treatment. The cryogen is delivered via a hose to a nozzle located in the handpiece. The Dynamic Cooling Device functions to cool the skin during the laser treatment minimizing thermal damage to skin during laser treatment and reducing pain associated with laser treatment. The Candela Smoothbeam Laser System is equipped with safety interlock systems to protect patients and operators. Users of the device, make selections from a control panel to regulate operation during the laser treatment.
Intended use of Smoothbeam Laser System: The Smoothbeam Laser System is indicated for the treatment of periorbital wrinkles.
Performance Standards: As a laser product, the Smoothbeam Laser System is required to conform and does conform to the Laser Performance Standard (21 CFR 1040). In addition, the device will conform to the UL 2601 Electrical Safety Standard and with the Harmonized Standard EN 60601-1-2, Part 2 established by the European Community.
Clinical Performance Data: Clinical trials produced results that the Smoothbeam Laser System is effective in the treatment of periorbital wrinkles.
Summary of Substantial Equivalence: The Candela Smoothbeam Laser System has the same intended use, 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. On the basis of similarities in methods of assembly, method of operation, and intended uses, Candela believes that its Smoothbeam Laser System is substantially equivalent to the predicate device.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a bird. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2002
Ms. Lorraine Nelson Manger, Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, MA 01778
Re: K013825
Trade/Device Name: Candela 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: Class II Product Code: GEX Dated: November 16, 2001 Received: November 19, 2001
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
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Page 2 - Ms. Lorraine Nelson
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.
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.qov/cdrh/dsma/dsmamain.html
Sincerely yours.
Muriam C. Provost
to" 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/3/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 divided into two sections, with the left section being solid black and the right section having diagonal lines. The word "CANDELA" is written in a simple, sans-serif font.
INDICATION FOR USE STATEMENT
510(k) Number (if known): K013825
Candela Corporation Smoothbeam Laser System Device Name: Indications For Use:
The Candela Smoothbeam Laser System is indicated for Use in dermatology for incision, excision, ablation, vaporization with hemostasis of soft tissue and the treatment of periorbital wrinkles.
The intended use of the Candela Dynamic Cooling Device is: Cooling of the skin prior to laser treatment Reduction of pain during laser treatment
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Muriam C. Provost
Division of General, Resto ative and Neurological Devices
CANDELA CORPORATIO 530 Boston Post Road, Month Not 508-358-7637 Fax: 508-358-5602 12 0