(313 days)
Not Found
Not Found
No
The summary describes a CO2 laser system for skin resurfacing and does not mention any AI or ML capabilities.
Yes
The device is described as a "Surgical Laser System" intended for skin resurfacing to treat conditions like wrinkles, rhytids, furrows, and acne scars, which are medical treatments for a disease, injury, or condition.
No
The device is described as a surgical laser system used for skin resurfacing applications such as treating wrinkles, rhytids, furrows, and acne scars. These are therapeutic applications, not diagnostic ones.
No
The device is described as a "CO2 Laser System," which inherently involves hardware components (the laser itself, delivery system, etc.) and is not solely software.
Based on the provided information, the Nideks UniPulse CO2 Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "skin resurfacing for the treatment of wrinkles, rhytids, furrows and acne scar revision." This is a therapeutic application performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The UniPulse system does not involve analyzing such samples.
- Device Description: While the device description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The lack of information in sections like "Mentions image processing," "Mentions AI, DNN, or ML," "Input Imaging Modality," and performance study details further supports that this is not an IVD, as these are often relevant for diagnostic devices.
In summary, the Nideks UniPulse CO2 Laser System is a therapeutic device used for skin treatment, not a diagnostic device that analyzes samples from the body.
N/A
Intended Use / Indications for Use
Nideks UniPulse CO2 Laser System is intended for all cleared Coherent CO2 skin resurfacing applications.
Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows and acne scar revision.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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)
Coherent's CO2 laser system.
Reference Device(s)
Not Found
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
DEC 16 1998
SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK UNIPULSE CO2 SURGICAL LASER SYSTEM
REGULATORY AUTHORITY:
Safe Medical Devices Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Ken Kato Vice President 47651 Westinghouse Drive Fremont, CA 94539 Phone: (510) 226-5700 Fax: (510) 226-5750
DEVICE TRADE NAME:
UniPulse CO2 Laser System
DEVICE COMMON NAME:
CO2 Surgical Laser System
DEVICE CLASSIFICATION:
CO2 laser systems are classified as Class II.
PERFORMANCE STANDARDS:
The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.
INDICATIONS FOR USE STATEMENT:
Nideks UniPulse CO2 Laser System is intended for all cleared Coherent CO2 skin resurfacing applications.
1
COMPARISON WITH PREDICATE DEVICE:
The Nidek CO2 system is substantially equivalent to Coherent's CO2 laser system.
The risks and benefits of the Nidek UniPulse CO2 are comparable to the predicate device when used for similar clinical applications.
Since the Nidek UniPulse CO2 laser system is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirement for substantial equivalence according to 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.
86
2
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 1998
Mr. Ken Kato Vice President of Administration Nidek, Incorporated 47651 Westinghouse Drive Fremont, California 94539
K980475 Re:
Trade Name: UniPulse CO, Surgical Laser System Regulatory Class: II Product Code: GEX Dated: November 30, 1998 Received: December 1, 1998
Dear Mr. Kato:
We have reviewed your Section 510(k) 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Ken Kato
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Scalef
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
4
Page 1 of 1
510(k) Number (if known): Device Name: Nidek UniPulse CO2 Laser System
Indications for Use: Plastic Surgery and Dermatology: UniPulse CO2 Surgical Laser Systems are intended for skin resurfacing for the treatment of wrinkles, rhytids, furrows and acne scar revision.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign-Off) (Divisiok (Division of General Restorative Devices (L g g O4 7 S 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use _