(44 days)
Not Found
No
The summary describes a mechanical compression tool and handpiece attachment accessories for a laser system, with no mention of software, algorithms, or any AI/ML related terms or concepts.
Yes
The device description clearly states its intended use is "to assist and enhance the procedure of treating dermatological conditions" and subsequently lists specific dermatological treatments such as "Tattoo Removal," "Hair Removal," "Vascular Lesions," etc. Additionally, it refers to the Medlite C-Series Nd: YAG Laser Systems, which are therapeutic lasers.
No
The device description states its purpose is "purely for a cosmetic end to help reduce undesirable purpura while treating with the Medlite C Series lasers," indicating it's used for treatment, not diagnosis. Its intended use also lists various treatments like tattoo removal, hair removal, and lesion ablation.
No
The device description explicitly states it is a "Compression Tool and Handpiece Attachment Accessories," which are physical components designed to accompany a laser system handpiece. This indicates it is a hardware accessory, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating dermatological conditions using a laser system. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as accessories to a laser system, designed to assist in the procedure and reduce purpura. This further reinforces its therapeutic/procedural nature.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
For use in dermatology for all currently approved indications for the Medlite C-Series Nd: YAG Laser Systems and MultiSpot Handpiece.
Tattoo Removal
Nevus of Ota
Hair Removal
Vascular Lesions
Dermal Pigmented Lesions
Epidermal Pigmented Lesions
Laser Resurfacing for Acne scars and wrinkles
Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Product codes (comma separated list FDA assigned to the subject device)
79-GEX
Device Description
The Compression Tool and Handpiece Attachment Accessories are intended to be used to assist and enhance the procedure of treating dermatological conditions The Compression Tool and Handpiece Attachment Accessories are additional accessories designed to accompany the currently offered MedLite MultiSpot Handpiece. The purpose for these accessories are purely for a cosmetic end to help reduce undesirable purpura while treating with the Medlite C Series lasers.
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)
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.
Candela Pigmented Lesion Compression Handpiece Accessory - K051359, Medlite C6 Q-Switched Nd: YAG Laser / Standard MultiSpot Handpiece Accessory - K014234
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
510(k) Summary or 510(k) Statement 5.
Medite C6 Q-Switched Nd: YAG Laser Medlite Compression Tool and Handpiece Attachment Accessories 510k Summary
Image /page/0/Picture/4 description: The image shows the logo for HOYA ConBio. Below the logo is the address 47733 Fremont Boulevard, Fremont, California 94538. The address is printed in a smaller font than the logo.
510-445-4500 www.conbio.com 510-445-4550 Fax
| Submitter: | Hoya ConBio, Inc.
47733 Fremont Blvd.
Fremont, California 94538
Phone: 510-445-4500
Fax: 510-445-4550 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Jim Green
Vice President of Engineering |
| Date Summary Prepared: | March 28, 2006 |
| Device Trade Name: | Medlite ™ Nd: YAG Laser System: Compression Tool and
Handpiece Accessory |
| Common Name: | Dermatology Laser System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.4810 |
| Equivalent Device: | Candela Pigmented Lesion Compression Handpiece
Accessory - K051359
Medlite ™ C6 Q-Switched Nd: YAG Laser / Standard
MultiSpot ™ Handpiece Accessory - K014234 |
| Device Description: | The Compression Tool and Handpiece Attachment
Accessories are intended to be used to assist and enhance
the procedure of treating dermatological conditions The
Compression Tool and Handpiece Attachment Accessories
are additional accessories designed to accompany the
currently offered MedLite MultiSpot Handpiece. The
purpose for these accessories are purely for a cosmetic end
to help reduce undesirable purpura while treating with the
Medlite C Series lasers. |
| Intended Use: | For use in dermatology for all currently approved indications
for the Medlite C-Series Nd: YAG Laser Systems and
MultiSpot Handpiece. |
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it consists of a staff with two snakes coiled around it and wings at the top. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2006
Hoya ConBio™ % Mr. Jim Green Vice President of Engineering 47733 Fremont Boulevard Fremont, California 94538
Re: K060977
Trade/Device Name: HOYA ConBio Compression Tool and Handpiece Accessories for use with MedLite™ C Series Q-Switched Nd: YAG Laser 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: April 6, 2006 Received: April 10, 2006
Dear Mr. Green:
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
2
Page 2 - Mr. Jim Green
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. 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 (240) 276-0115. 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,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement 4.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
HOYA ConBio Compression Tool and Handpiece Accessories for use with the MedLite™ C Series Q- Switched Nd: YAG Laser Systems.
Indications for Use: Tattoo Removal
Nevus of Ota Hair Removal Vascular Lesions Dermal Pigmented Lesions Epidermal Pigmented Lesions Laser Resurfacing for Acne scars and wrinkles Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) (Division Sign-Villancurrence of CDRH, Office of Device Evaluation (ODE) Division of General, Restorative,
and Neurological Devices
Page of (Posted November 13, 2003)
510(k) Number_koso977
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