(332 days)
Not Found
None
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on standard laser system components.
Yes
The device is indicated to "treat moderate inflammatory acne vulgaris", which is a therapeutic purpose.
No
The device is indicated to treat inflammatory acne, which is a therapeutic rather than diagnostic use. It treats a condition, it does not identify or characterize one.
No
The device description explicitly lists multiple hardware components, including a Laser Console, Fiber Port, Control and Display Panels, Footswitch and Handswitch Delivery Controls, Accessories, and a Cooling Sub-system, in addition to operating software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat moderate inflammatory acne vulgaris." This describes a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser system designed for surgical or therapeutic procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: The information does not mention any components or functions related to collecting, processing, or analyzing biological specimens (like blood, urine, tissue, etc.), which are fundamental to IVDs.
Therefore, the Laserscope Aura i Laser System & Accessories is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Laserscope Aura i Laser System is indicated to treat moderate inflammatory acne vulgaris.
Product codes
GEX
Device Description
The Laserscope Aura i Surgical Laser System & Accessories are comprised of the following main components:
- A Laser Console
- A Fiber Port (for Delivery Devices)
- Control and Display Panels
- Operating Software
- Footswitch and Handswitch Delivery Controls
- Accessories
- A Cooling Sub-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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Laserscope Aura™ Laser System and Accessories, Clearlight Phototherapy System Model C420 (ClearLight™, Lumenis)
Reference Device(s)
Laserscope Lyra Laser System and Accessories; and, the Modified Coherent VersaPulse Select Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices and Accessories.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko24206 1/2
NOV. 1 7 2003
510(k) Summary Statement For the AURA™ i Surgical Laser System & Accessories for the Treatment of Moderate Acne vulgaris
General Information
- A. Trade Name Aura™ i Surgical Laser System & Accessories
- B. Common Name Laser Instrument, Surgical, Powered
- C. Establishment Registration Number
2937094
- D. Manufacturer's Identification
Laserscope 3070 Orchard Drive San Jose, CA 95134-2011 (408) 943-0636 (503) 961-1688 FAX
Official Correspondent Paul Hardiman Manager, Regulatory Affairs/Clinical Affairs
-
E. Device Classification
The Aura i Surgical Laser System has been specifically classified as a Class II medical device by the OB/GYN, General Plastic Surgery, and ENT Device Advisory Panels. -
F. Performance Standards
The Aura i Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems. -
G. Predicate Devices:
- Laserscope Aura™ Laser System and Accessories ●
- Clearlight Phototherapy System Model C420 (ClearLight™, Lumenis) .
1
H. Product Description:
The Laserscope Aura i Surgical Laser System & Accessories are comprised of the following main components:
- A Laser Console ●
- A Fiber Port (for Delivery Devices) 0
- Control and Display Panels .
- Operating Software ●
- Footswitch and Handswitch Delivery Controls .
- . Accessories
- A Cooling Sub-system ●
-
- Indications For Use:
The Laserscope Aura i Laser System is indicated to treat moderate inflammatory acne vulgaris.
- . ل. Rationale for Substantial Equivalence
The Laserscope Aura i Laser System & Accessories and the ClearLight Phototherapy System, Model CL 420 share the same indications for use, similar design features, functional features, and therefore are substantially equivalent to: Laserscope Lyra Laser System and Accessories; and, the Modified Coherent VersaPulse Select Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers and Delivery Devices and Accessories. Details are provided in the Substantial Equivalence Section of this submission.
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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three intertwined strands and a single wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
NOV 17 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Paul H. Hardiman Manager, Regulatory Affairs Laserscope 3070 Orchard Drive San Jose, California 95134-2011
Re: K024206
Trade/Device Name: Aura™i Surgical Laser System and Accessories 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: September 16, 2003 Received: September 17, 2003
Dear Mr. Hardiman:
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. Paul H. Hardiman
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. 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 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
4
INDICATIONS FOR USE STATEMENT
Page 1
510(k) Number:
027206
Device Name:
AURA i SURGICAL LASER SYSTEM & ACCESSORIES
INTENDED USE:
The Laserscope Aura i Laser System & Accessories is indicated to treat moderate inflamatory acne vulgaris.
(Please Do Not WRITE BELOW THIS LINE - Continue on another Page)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use: or Over The-Counter-Use (per 21 CFR 801.109)
Miriam C. Provost
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K024206
000002