(193 days)
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Not Found
No
The device description focuses on laser technology and standard control mechanisms (touch screen, switches). There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
No.
The device is intended for hair removal and permanent hair reduction, which is generally considered a cosmetic procedure rather than a therapeutic one. Therapeutic devices are typically used to treat or cure diseases, disorders, or injuries.
No
The device is described as a hair removal and permanent hair reduction system, and its description focuses on the technical aspects of delivering laser light for this purpose. There is no mention of it being used to diagnose any condition or disease.
No
The device description clearly outlines hardware components including a console, handpiece with diode lasers, umbilical, touch screen, skin touch switch, trigger, footswitch, and a cryogen spray mechanism. While it has a computer and touch screen interface, it is fundamentally a hardware-based laser system for hair removal.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "hair removal and permanent hair reduction." This is a therapeutic/cosmetic application performed directly on the patient's body.
- Device Description: The device delivers laser light to the skin. This is an external application, not a test performed on biological samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The TERABYTE 2000 System does not fit this description.
N/A
Intended Use / Indications for Use
TERABYTE 2000 System is intended for hair removal and permanent hair reduction. The TERABYTE 2000 System is intended for use on all skin types (Fitzpatrick Skin Types ) , including tan skin. The device is intended for prescription use.
Product codes
GEX
Device Description
TERABYTE 2000 Hair Remover delivers pulsed infrared laser light at a wavelength of 810 nm with selectable pulse duration of 5 - 50 ms, and a selectable fluence of 10 -65 J/cm². The laser pulses are capable of generating a maximum pulse repetition frequency of 1 Hz by several arrays of diode lasers located in the handpiece.
The complete system consists of a console and handpiece connected to the system by an umbilical. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output the system requires the set up of the touch screen , and concurrent activation of the following : the handpiece skin touch switch, handpiece trigger , and footswitch. The cryogen is splayed from the top of the handpiece to provide active skin cooling. Laser parameters and other system features are controlled from the touch screen on top of the console, which provides an interface to the system computer.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None.
The specifications and indications for use of the TERABYTE 2000 System are the same or very similar to those of the claimed predicate devices. The TERABYTE 2000 System has the same or very similar indications for which the claimed predicates have been cleared. Because of this, performance data were not required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Summary of Safety and Effectiveness 510(K)
Applicant : TERABYTE Company
V 022341
Address : 5480 Hirakuchi, Hamakita · ity, Shizuoka · Prefecture, 434-0041 Japan
Contact : Dr. William A. Olson, U.S Authorized Agent
Telephone: 703 590 7337
Preparation Date :
Device Trade Name : TERABYTE 2000 Hair Remover
Common Name : Laser Instrument for hair removal
Classification Name :
Laser surgical instrument for use in General and Plastic Surgery and in Dermatology (see 21 CFR 878.4810) Product code:GEX Panel:79.
Legally-marketed Predicate Devices :
Coherent Inc., Light Sheer Family
( Light Sheer SP, Light Sheer EP, Light Sheer SC, and Light Sheer EC ) Cynosure Corp., Apogee 6200, and Apogee 9300
System Description :
TERABYTE 2000 Hair Remover delivers pulsed infrared laser light at a wavelength of 810 nm with selectable pulse duration of 5 - 50 ms, and a selectable fluence of 10 -65 J/cm². The laser pulses are capable of generating a maximum pulse repetition frequency of 1 Hz by several arrays of diode lasers located in the handpiece.
The complete system consists of a console and handpiece connected to the system by an umbilical. In standard use, the handpiece is pressed against the patient's skin and a pulse of light is delivered. To initiate energy output the system requires the set up of
1
the touch screen , and concurrent activation of the following : the handpiece skin touch switch, handpiece trigger , and footswitch. The cryogen is splayed from the top of the handpiece to provide active skin cooling. Laser parameters and other system features are controlled from the touch screen on top of the console, which provides an interface to the system computer.
Intended Use of the Device :
TERABYTE 2000 System is intended for hair removal and permanent hair reduction. The TERABYTE 2000 System is intended for use on all skin types (Fitzpatrick Skin Types ) , including tan skin. The device is intended for prescription use.
Performance Data :
None.
The specifications and indications for use of the TERABYTE 2000 System are the same or very similar to those of the claimed predicate devices. The TERABYTE 2000 System has the same or very similar indications for which the claimed predicates have been cleared. Because of this, performance data were not required.
Conclusion:
Based on the foregoing, the TERABYTE 2000 System is substantially equivalent to the legally marketed claimed predicate device for the purpose of this 510(K) submission.
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Image /page/2/Picture/1 description: The image contains the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text appears to be extracted from a document or sign.
Image /page/2/Picture/2 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 a stylized symbol that resembles three overlapping human figures or abstract shapes.
JAN 2 7 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 2:0850
Terabyte Company William A. Olson c/o Center for Regulatory Services, Inc. 5200 Wolf Run Shoals Road Woodbridge, Virginia 22192
Re: K022341 Trade/Device Name: Terabyte 2000 Hair Remover Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic Surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: October 28, 2002 Received: October 29, 2002
Dear Mr. Olson:
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
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Page 2 -- Mr. William A. Olson
(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. 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). Other general information on your responsibilities under the Act may be obtained 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
for 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
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510(k) Number: K022341
DEVICE NAME: TERABYTE 2000 Hair Remover
INDICATIONS FOR USE:
TERABYTE 2000 System is intended for hair removal and permanent hair reduction.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 OR
Over-the-Counter-Use (Optional Format 1-2-96)
Miriam C. Provost
eral. Pestorative and Neurological Dev
) Number K022341