(25 days)
Not Found
Not Found
No
The summary describes a laser surgical instrument and does not mention any AI or ML capabilities.
Yes
The device is indicated for the treatment of various medical conditions such as benign cutaneous vascular lesions, benign pigmented lesions, and mild to moderate inflammatory Acne Vulgaris, which are therapeutic uses.
No
The device description focuses on its therapeutic uses (hair reduction, treatment of vascular/pigmented lesions, acne), not on identifying or diagnosing medical conditions.
No
The device description explicitly states "Intense Pulsed Light Source," which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the iPulse System is a "laser surgical instrument" used for procedures performed on the patient (hair reduction, treatment of lesions, treatment of acne). IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health.
- Device Description: It's described as an "Intense Pulsed Light Source," which is a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The description lacks any mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory tests.
Therefore, the iPulse System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The iPulse System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology and specifically for long term stable, or permanent, hair reduction.
In addition, the iPulse System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions.
The iPulse System is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.
Product codes
GEX
Device Description
Not Found
Mentions image processing
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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
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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)
Not Found
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.
Not Found
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
Ko80406
Image /page/0/Picture/1 description: The image contains the logo "CyDen". The logo consists of a stylized letter "C" on the left, followed by the text "CyDen" in a bold, sans-serif font. The overall impression is a clean and modern design.
MAR 1 0 2008
FDA Center for Devices and Radiological Health Document Mail Center, HFZ-401 9200 Corporate Boulevard Rockville, MD 20850
FDA CDRH DMC
FEB 1 4 2008
Received
8th February 2008
510(k) Notification
The document in intended to provide the necessary information required by the FDA for the pre-market 510(k) approval for the iPulse i400 System
| 510(k) Administration Information | |
|---|---|
| Submitter: | Cyden Limited |
| Technium, Kings Road, The Docks | |
| Swansea SA1 8PH, Wales, UK | |
| Official Contact: | Dr Mike Kiernan |
| Consultant | |
| Telephone: | UK +44 1792 485682 |
| Fax: | UK +44 1792 485524 |
| Email: | mikekiernan@hotmail.com |
| Submission Type: | SPECIAL 510(k) |
| Device Type: | Intense Pulsed Light Source |
| Classification | |
| Regulation: | The iPulse System is a Laser Surgical |
| Instrument for use in General and Plastic | |
| Surgery and in Dermatology and therefore is | |
| classified under 21 CFR 878.4810 | |
| Class: | Class II |
| Panel: | General and Plastic Surgery |
| Product Code: | GEX - Laser Powered Surgical Instruments |
| (and Accessories) | |
| Submission Basis: | Modification to Existing Device |
1
In accordance with the guidelines, the principle factors about the design and use of the device are tabulated in Table 1.
| Table 1: Design and Use of the Device | ||
|---|---|---|
| YES | NO | |
| Is the device intended for prescription use (21 CFR 801 Subpart D)? | YES | |
| Is the device intened for over-the-counter use (21 CFR 807 Subpart C)? | YES | |
| Does the device contain components derived from a tissue or other | ||
| biological source? | NO | |
| Is the device provided sterile? | NO | |
| Is the device intended for single use? | NO | |
| Is the device a reprocessed single use device? | NO | |
| If yes, does this device type require reprocessed validation data? | N/A | |
| Does the device contain a drug? | NO | |
| Does the device contain a biologic? | NO | |
| Does the device use software? | YES | |
| Does the submission include clinical information? | NO | |
| Is the device implanted? | NO |
Please call me on the above number if you have any queries or comments.
Signature
Dr Mike Kiernan Consultant
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 stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
CyDen Limited % Dr. Mike Kiernan Technium, Kings Road The Docks Swansea, SA1 8PH Wales, UK
Re: K080406
Trade/Device Name: IPL iPulse i400 Systems 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: March 3, 2008 Received: March 5, 2008
MAR 1 0 2008
Dear Dr. Kiernan:
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. Iisting 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
3
Page 2 - Ms. Sharon Rockwell
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Mulhausen
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
f 0406
Indications for Use Statement
510(k) Number (if known): Unknown
Device Name: IPL iPulse i400 System
Indications For Use:
The iPulse System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology and specifically for long term stable, or permanent, hair reduction.
In addition, the iPulse System is indicated for the treatment of benign cutaneous vascular lesions and the treatment of benign pigmented lesions.
The iPulse System is indicated for the treatment of mild to moderate inflammatory Acne Vulgaris.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
NeR.P.S.h. Sormxn
(Division S Division of General, Restorative, and Neurological Devices
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510(k) Number K080406