(154 days)
Not Found
No
The device description focuses on the laser technology and its parameters (wavelength, spot size, pulse duration, energy density). There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The performance studies section is empty, further indicating a lack of AI/ML components that would typically require validation data.
No
Explanation: The device is indicated for hair removal, which is a cosmetic procedure and not a therapeutic medical condition.
No
Explanation: The device is indicated for hair removal, which is a treatment, not a diagnostic purpose.
No
The device description clearly states it is a "semiconductor diode laser system" and describes hardware components like laser light delivery, spot sizes, pulse duration, and energy density. This indicates it is a hardware device with potentially integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hair removal." This is a cosmetic or therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a laser system that delivers light energy to the skin. This is an external application, not a test performed on a biological sample in vitro (outside the body).
- 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 biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. The IRIDERM Apex 800 is a device used for a physical procedure on the body itself.
N/A
Intended Use / Indications for Use
The IRIDERM Apex 800 is indicated for hair removal.
Product codes
79 GEX
Device Description
The IRIDERM Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm, 8.5 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40, 32 and 23 J/cm2 for spot sizes of 7, 8.5 and 10 mm respectively. Visible red (630-650 nm) semiconductor diode lasers are used for aiming.
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)
Non-Clinical performance Data: None
Clinical performance Data: None
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
K992298
DEC - 9 1999
510(k) Summarv IRIDEX Corporation IRIDERM Apex 800
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Bradlev J. Renton, Ph.D. IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043 (650) 962-8100
Contact Person: (same as above)
Date Prepared: July 2, 1999
Name of Device and Name/Address of Sponsor
IRIDERM Apex 800
IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, CA 94043
Classification Name
Laser Instrument, Surgical, Powered CFR Section: 878.4810 Product Code: 79 GEX
Predicate Devices
The IRIDERM Apex 800 Dermatology Laser System is substantially equivalent to other currently legally marketed dermatology laser devices including the Cynosure, Inc., PhotoGenica LPIR (K971737) and the Coherent, Inc., LightSheer (K973324).
Device Description
The IRIDERM Apex 800 is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm, 8.5 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40, 32 and 23 J/cm2 for spot sizes of 7, 8.5 and 10 mm respectively. Visible red (630-650 nm) semiconductor diode lasers are used for aiming.
Intended Use
The IRIDERM Apex 800 is indicated for hair removal.
1
Technological Characteristics and Substantial Equivalence
The IRIDERM Apex 800 is substantially equivalent to other currently legally marketed dermatology laser devices including the Cynosure, Inc., PhotoGenica LPIR (K971737) and the Coherent, Inc., LightSheer (K973324). These predicate devices are indicated for hair removal.
The IRIDERM Apex 800 is a semiconductor diode laser system that delivers infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm, 8.5 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40, 32 and 23 J/cm² for spot sizes of 7, 8.5 and 10 mm respectively.
The Cynosure, Inc., PhotoGenica LPIR (K971737) delivers pulsed infrared 755 nm laser light intended to be used for the indication of hair removal. Energy is delivered into treatment spots of 7 mm or 10 mm diameter. The Pulse Duration can be selected from 5 to 20 msec. The maximum Energy Density that can be delivered is dependent on the diameter of the treatment spot and is 40 and 25 J/cm² for spot sizes of 7 and 10 mm respectively.
The Coherent, Inc., LightSheer (K973324) is a semiconductor diode laser system that delivers pulsed infrared 800 nm laser light intended to be used for the indication of hair removal. Energy is delivered into a 9 mm square treatment spot. The Pulse Duration can be selected from 5 to 30 msec. The maximum Energy Density that can be delivered is 40 J/cm2.
Non-Clinical performance Data: None
Clinical performance Data: None
Conclusion
The IRIDERM Apex 800 is substantially equivalent to predicate devices currently legally marketed for the indication of hair removal.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 1999
Bradley J. Renton, Ph.D. Vice President, Dermatology IRIDEX Corporation 1212 Terra Bella Avenue Mountain View, California 94043
Re: K992298 Trade Name: IRIDERM Apex 800 Regulatory Class: II Product Code: GEX Dated: September 29, 1999 Received: September 30, 1999
Dear Dr. Renton :
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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
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Page 2 - Bradley J. Renton, Ph.D.
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,
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | Pending K992279 |
|---|---|
| --------------------------- | ----------------- |
Device Name: IRIDERM Apex 800
Indications For Use:
The IRIDERM Apex 800 is indicated for hair removal.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pcoellyo
(Division Sign-Off)
Division of General Restorative Devices K992298
510(k) Number
Prescription Use
OR (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________