(90 days)
No
The summary describes a laser device with a standard user interface and delivery system, with no mention of AI, ML, or related concepts like image processing or training/test sets.
Yes
The device is intended for the treatment of vascular and pigmented lesions, which directly addresses a health condition.
No
Explanation: The device is described as a laser intended for the treatment of vascular and pigmented lesions, indicating a therapeutic rather than a diagnostic purpose. There is no mention of it being used to identify or analyze medical conditions.
No
The device description explicitly states it consists of a cabinet, fiber optic delivery system, and a user/software interface, indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of vascular and pigmented lesions." 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 device used for emitting energy, which aligns with a treatment modality, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis or disease status
Therefore, the Dual Yellow Laser, as described, is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Dual Yellow Laser is intended for the treatment of vascular and pigmented lesions.
Product codes
GEX
Device Description
The Norseld Dual Yellow D10B Laser is a copper bromide laser which emits it energy at 511 and 578 nm. The device consists of an cabinet, fiber optic delivery system, and a user/software interface.
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
licensed professionals
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)
The Dual Yellow D10B Laser has the same specifications and indications for use as the YellowStar Laser (K013940) which is also manufactured by Norseld, Pty., Ltd.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
YellowStar Laser System
Reference Device(s)
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
SECTION 8
510(k) SUMMARY
K0 23899
This 510(k) summary of safety and effectiveness for Norseld Dual Yellow D10B laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
- Applicant: Norseld Pty., Ltd.
- Address: 9 Claxton St Adelaide South Australia 5000
- Manufacturer: Norseld Pty, Ltd. 9 Claxton St Adelaide South Australia 5000
- Contact Person: Mr. Peter Davis Managing Director
- Telephone: +618 82319000
Preparation Date: November 2002 (of the Summary)
- Device Name: Dual Yellow D10B Laser
- Common Name: Laser surgical device
Classification: Laser surgical device Class II medical device 21 CFR 878.4810
Product Code: GEX Panel: 79
Predicate devices: YellowStar Laser System
Device description: The Norseld Dual Yellow D10B Laser is a copper bromide laser which emits it energy at 511 and 578 nm. The device consists of an cabinet, fiber optic delivery system, and a user/software interface.
- Indications: The Dual Yellow Laser is intended for treatment of vascular and pigmented lesions.
1
The Dual Yellow Laser is a restricted device and is labeled:
"CAUTION: Federal (US) law restricts this device to sale to or use by licensed professionals."
- Performance Data: The Dual Yellow D10B Laser has the same specifications and indications for use as the YellowStar Laser (K013940) which is also manufactured by Norseld, Pty., Ltd.
- CONCLUSION: Based on the information in the notification Norseld Pty., Ltd. believes that Dual Yellow D10B Laser is substantially equivalent to (i.e., the same as) the YellowStar Laser System.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of what appears to be an abstract human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2003
Mr. Roger Barnes Regulatory Consultant Norseld Pty., Ltd. 342 Sunset Bay Road Hot Springs, Arkansas 71913
Re: K023899 Trade Name: Dual Yellow D10BLaser 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 20, 2002 Received: November 22, 2002
Dear Mr. Barnes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Roger Barnes
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,
Muriam C. Provost
(or 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
SECTION 6
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K023899 |
|---|---|
| --------------------------- | --------- |
Device Name: Norseld Pty., Ltd. Dual Yellow D10B Laser
Indications for Use Statement:
The Dual Yellow Laser is intended for the treatment of vascular and pigmented lesions.
The Dual Yellow Laser is also labeled as a restricted device:
"CAUTION: Federal (US) law restricts this device to sale to or use by licensed professionals."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use _X (Per 21 CFR 801.109) OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023899
012