(22 days)
Not Found
No
The device description focuses on the physical properties and operation of a laser system, with no mention of AI or ML capabilities for image processing, data analysis, or treatment planning.
Yes
The device is described with indications for the treatment of various medical conditions and procedures, such as removal of tattoos, pigmented lesions, vascular lesions, and treatment of acne scars and wrinkles. These applications directly relate to the diagnosis, cure, mitigation, treatment, or prevention of disease, or affecting the structure or any function of the body, which aligns with the definition of a therapeutic device.
No
The device description focuses on the therapeutic actions of the laser (incision, excision, ablation, vaporization, removal of tattoos and lesions, skin resurfacing) rather than the diagnosis of conditions. It describes how the laser energy is absorbed by tissues to achieve these effects.
No
The device description clearly describes a physical laser system with an articulated arm and handpiece, indicating it is a hardware device, not software-only.
Based on the provided information, the Spectra VRMII Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Spectra VRMII Function: The Spectra VRMII Laser System is a medical device that uses laser energy to directly interact with and modify soft tissues on the human body. It is used for procedures like incision, excision, ablation, and vaporization, as well as targeting specific chromophores (like melanin and tattoo ink) within the tissue for removal or treatment.
- Lack of Sample Analysis: The description does not mention any analysis of samples taken from the body. The laser is applied to the body.
Therefore, the Spectra VRMII Laser System falls under the category of a therapeutic or surgical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Spectra VRMII Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
- 532nm Wavelength : Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Café-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus
- 1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation. Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles
Product codes
GEX
Device Description
The Spectra VRMII Laser System produces a pulsed beam of coherent near infrared (1064 nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles.
By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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)
None presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
the Lutronic Spectra QT Q-switched Nd: YAG Laser System, the Tissue Medical Spectra-VRM Q-switched Nd: Y AG Laser System, the Altus Medical CoolGlide Aesthetic Lasers, the Fotona QX Nd: YAG/KTP Laser System and the NaturaLase LP with 532 Hand Piece.
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
DEC 28 2007
K073436 page 1/2
510(k) Summary for the Lutronic Corporation Spectra VRMII Laser System
This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Submitter:
Lutronic Corporation #403-2,3,4, Ilsan Technotown 1141-1 Baeksok-Dong, Ilsan-Gu Goyang-Si, Gyeonggi-Do, 410-722 Republic of Korea
Contact Person:
Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: 978-207-1245 Fax: 978-207-1246
Summary Preparation Date:
December 20, 2007
- Names
Device Name:
Spectra VRMII (Q-Switched Nd:YAG) Laser System
Classification Name:
Laser Instrument, Surgical, Powered Product Code: GEX Panel: General & Plastic Surgery
3. Predicate Devices
The Spectra VRMII Laser System is substantially equivalent to the Lutronic Spectra QT Q-switched Nd: YAG Laser System, the Tissue Medical Spectra-VRM Q-switched Nd: Y AG Laser System, the Altus Medical CoolGlide Aesthetic Lasers, the Fotona QX Nd: YAG/KTP Laser System and the NaturaLase LP with 532 Hand Piece.
4. Device Description
The Spectra VRMII Laser System produces a pulsed beam of coherent near infrared (1064 nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. When the
1
K073436 Page 2/2
beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles.
By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.
5. Indications for Use
The Spectra VRMII Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
- . 532nm Wavelength : Removal of light ink (Red, Tan, Purple, and Orange)
Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Café-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength: Removal of dark ink (Black, Blue and Brown)
Tattoos
Removal of Nevus of Ota
Removal of lightening of unwanted hair with or without
adjuvant preparation.
Treatment of Common Nevi
Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Performance Data
None presented.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other.
DEC 2 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lutronic Corporation % O'Connell Regulatory Consultants Ms. Maureen O'Connell 5 Timber Lane North Ridge, Massachusetts 01864
Re: K073436
Trade/Device Name: Spectra VRMII Laser System Regulatory Number: 21 CFR 878.4810 Regulatory Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 5, 2007 Received: December 6, 2007
Dear Ms. O'Connell:
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
3
Page 2 - Ms. Maureen O'Connell
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 Mullerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K073436
Device Name: Spectra VRMII Laser System
Indications for Use:
The Spectra VRMII Laser System in indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
- 532nm Wavelength : Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions Treatment of Lentigines Treatment of Café-Au-Lait Treatment of Seborrheic Keratoses Treatment of Post Inflammatory Hyper-Pigmentation Treatment of Becker's Nevi, Freckles and Nevi Spilus
1064nm Wavelength: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation. Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
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)
Larry D. Taylor
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K073436 510(k) Number