(55 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical characteristics and intended uses of a pulsed light system.
Yes
The device is intended for the treatment of various medical conditions, such as dermatological vascular lesions, benign pigmented lesions, and inflammatory acne, which are therapeutic applications.
No
The device is intended for therapeutic and cosmetic applications (hair reduction, treatment of vascular/pigmented lesions, acne), not for diagnosing conditions.
No
The device description clearly indicates it is a hardware system (pulsed light system with handpiece, foot switch, weight, and dimensions) and not software only.
Based on the provided information, the Blueshine Light Shine device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for various dermatological treatments applied directly to the patient's body (hair reduction, vascular lesions, pigmented lesions, acne). IVDs are used to examine specimens taken from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a pulsed light system with handpieces and a foot switch, consistent with a device used for external treatments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Blueshine Light Shine is a therapeutic device used for external dermatological applications, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Blueshine Light Shine is intended for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions and inflammatory acne (acne vulgaris) It can be used for all skin types, from I (subjects with white skin, freckles, blond or red hair, blue or green eyes) to VI (subjects with brown to dark skin/ brown or black hair/ brown eyes included suntanned skin).
The Blueshine Light Shine system is Indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photermolysis of blood vessels (treatment of facial and leg velns), and treatment of benign pigmented leslons. It is also indicated for treatment of inflammatory acne (acne vulgaris).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Blueshine Light Shine System is a pulsed light, wavelength range adjustable system. It provides selectable handpiece aperture sizes for a variety of applications Light emission activation is by foot switch. Overall weight of the system is 110lbs., and the size is 57x56x98cm (LxWxH). Electrical requirement is 110 VAC, 16A, 50-60 Hz, single phase.
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)
Nonclinical Performance Data: None
Clinical Performance Data: None
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.
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
| Submitter: | Blueshine Sr.l. -- Unipersonale
Via Olivi, 2
30171 Mestre
VE/Italy
Ph. 0039 041 5055847 |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NOV 2 9 2006 |
| Facility description: | Placed on 500 m², Blueshine Company is divided
in accounting, commercial and technical
departments, wares receipt and storage areas,
warehouse, hydraulic, electronic, optical
assembly areas, final test area and shipping
division. The production, for some part, is in
outsourcing, receiving half-assemblied and
assemblied products from its suppliers. |
| Contact: | Ms. Alice Novelli
Quality and Certification Dept. |
| Date Summary Prepared: | May 23, 2006 |
| Device Trade Name: | Blueshine Light Shine system |
| Common Name: | Pulsed Light System |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CFR 878.410 |
| Equivalent Device: | Radiancy (Israel) Ltd Skinstation system, cleared
for commercial distribution by the FDA on June
19, 2003 under 510(k) notification No. K030897
and Sciton, Inc. Profile BBL system cleared for
commercial distribution by the FDA on November
11, 2003 under 510 (k) notification No. K032460 |
| Device Description: | The Blueshine Light Shine System is a pulsed
light, wavelength range adjustable system. It
provides selectable handpiece aperture sizes for
a variety of applications |
| | Light emission activation is by foot switch.
Overall weight of the system is 110lbs., and the
size is 57x56x98cm (LxWxH). |
| | Electrical requirement is 110 VAC, 16A, 50-60
Hz, single phase. |
1
| Intended Use: | The Blueshine Light Shine is intended for
permanent hair reduction, photocoagulation of
dermatological vascular lesions,
photothermolysis of blood vessels (treatment of
facial and leg veins), and treatment of benign
pigmented lesions and inflammatory acne (acne
vulgaris)
It can be used for all skin types, from I (subjects
with white skin, freckles, blond or red hair, blue
or green eyes) to VI (subjects with brown to
dark skin/ brown or black hair/ brown eyes
included suntanned skin). |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison: | The Blueshine Light Shine system has similar
indications for use, the same principle of
operation, and essentially the same wavelength
range and pulse energy range as the predicate
devices. |
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Blueshine Light Shine system is a safe and
effective device for the indicated uses. |
| Additional Information: | none |
:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Blueshine SRL c/o Mark Job Regulatory Technology Scrvices, Inc. 1394 25th Street, NW Buffalo, MN 55313
NOV 2 9 2006
Re: K063060
Trade/Device Name: Blueshine Light Shine Systems: SP, Twin, and Compact SP Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: Class II Product Code: GEX Dated: November 13, 2006 Received: November 14, 2006
Dear Mr. Job:
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 (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Mr. Mark Job
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely your
Pa. M
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Blueshine Light Shine systems; SP, Twin and Compact SP
Indications For Use:
The Blueshine Light Shine system is Indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photermolysis of blood vessels (treatment of facial and leg velns), and treatment of benign pigmented leslons.
It is also indicated for treatment of inflammatory acne (acne vulgaris).
Prescriptive Use_ x OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 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)
(Division Sign-Off Division of Generaly-Restorative, FR +30.41 606547 + FR +30.01 16820 + Blacker (2008) 1982) 2007 1982 1000 19620 1982 1983 1983 1983 1983 1983 1983 1983 1983 1983 1983 1983 1 and Neurological Devices
510(k) Number K063060