(139 days)
Not Found
No
The summary describes a multi-functional light and laser system with standard operational principles and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for the treatment of various medical conditions, including benign epidermal lesions, cutaneous lesions, benign cutaneous vascular lesions, and for the coagulation and hemostasis of vascular lesions and soft tissue, which falls under the definition of a therapeutic device.
No
The device is indicated for treatment of various skin conditions and hair removal, not for diagnosis.
No
The device description clearly states it is a "multi-functional platform, computer controlled system which incorporates two technologies and two treatment heads: Intense Pulsed Light (IPL), and Nd:YAG Laser." It also describes physical components like a console, treatment heads, flexible cable, and a cooling system, indicating it is a hardware device with integrated software.
Based on the provided text, the Lume 2 device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended uses listed for the Lume 2 are all related to treating various skin conditions and removing unwanted hair. These are direct treatments applied to the patient's body.
- Device Description: The description details a system that delivers Intense Pulsed Light (IPL) and Nd:YAG Laser energy to the patient's skin. This is a therapeutic device, not a device used to examine specimens taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD.
Therefore, the Lume 2 is a therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The Lume 2, with Intense Pulsed Light (IPL) wavelengths 515-1200 nm, is indicated for the treatment of: Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos. Cutaneous lesions, including warts, scars and striae. Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
with Nd:YAG laser at wavelength 1064 nm, is indicated for: The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles. The non-ablative treatment of facial wrinkles.
Product codes
GEX
Device Description
The Lume 2 system is a multi-functional platform, computer controlled system which incorporates two technologies and two treatment heads: Intense Pulsed Light (IPL), and Nd:YAG Laser. The Lume 2 console has a single treatment head connection port that accommodates either the Universal IPL or the Multi-Spot Nd: YAG treatment head. The treatment heads are attached to the head connector via a flexible cable (umbilical). During operation, deionized water circulates from the system console through the umbilical cable to the treatment heads to cool the flashlamp assembly and/ or the laser head, and the umbilical cable also houses the power cable to provide energy to the light/laser emission and the electrical wiring to power the thermoelectric (TE) cooler. The energy is delivered in pulse sequences, to allow better control. The principles of operation and fundamental scientific technology are the same for the subject devices and predicate device.
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)
The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Lume 2 system has been conducted.
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is accordance with the requirements of SMDA 1990.
A. SUBMITTER INFORMATION:
Submitter's Name: Address:
Contact: Phone: Fax: Date of Preparation: Frances E. Harrison 770-630-3281 801-656-2627
December 15, 2008
3959 West 1820 South Salt Lake City, UT 84104
Lumenis, Inc.
B. DEVICE NAME:
Trade Name(s): Common/Usual Name: Classification Names:
CFR Reference:
Lume 2 System Laser instrument, surgical, powered 79 GEX, Laser Powered Surgical Instrument
21 CFR 878.4810, Laser surgical instrument for use in general and plastic surgery and in dermatology
KOX3733
C. Predicate device:
Lumenis One Family of Systems (K060448)
D. DEVICE DESCRIPTION:
The Lume 2 system is a multi-functional platform, computer controlled system which incorporates two technologies and two treatment heads: Intense Pulsed Light (IPL), and Nd:YAG Laser.
The Lume 2 console has a single treatment head connection port that accommodates either the Universal IPL or the Multi-Spot Nd: YAG treatment head.
The treatment heads are attached to the head connector via a flexible cable (umbilical). During operation, deionized water circulates from the system console through the umbilical cable to the treatment heads to cool the flashlamp assembly and/ or the laser head, and the umbilical cable also houses the power cable to provide energy to the light/laser emission and the electrical wiring to power the thermoelectric (TE) cooler. The energy is delivered in pulse sequences, to allow better control.
The principles of operation and fundamental scientific technology are the same for the subject devices and predicate device.
E. Intended Use:
The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of:
1
Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos.
Cutaneous lesions, including warts, scars and striae.
Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and
For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
with Nd:YAG laser at wavelength 1064 nm, is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1-4.0 mm. diameter) of the leg
The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The non-ablative treatment of facial wrinkles.
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
u. TECHNOLOGICAL CHARACTERISTICS SUMMARY AND SUBSTANTIAL EQUIVALENCE STATEMENT:
The subject device, the Lume 2 system, has the same intended use, general design and fundamental scientific technology as the predicate device (K060448),
The Lume 2 system uses technology substantially equivalent to the Lumenis One Family of Systems (K060448). There are no new hazards introduced by the Lume 2 System as compared with the predicate devices.
G. Performance Data Summary:
The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Lume 2 system has been conducted.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
MAY - 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lumenis, Ltd. % Ms. Frances E. Harrison Global VP, Regulatory Affairs/ Quality Compliance 3959 West 1820 South Salt Lake City, Utah 84104
Re: K083733
Trade/Device Name: Lume 2 Intense Pulsed Light & Laser System and delivery devices 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 1, 2009 Received: April 3, 2009
Dear Ms. Harrison:
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
3
Page 2 - Ms. Frances E. Harrison
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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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,
Center for Devices and Radiological Health
For Volo
Mark N. Melkerson
Director
Der D.n
Division of Surgical, Orthopedic,
and Restorative Devices
Office of Device Evaluation
Enclosure
4
1.3 Indications for Use Statement
510(k) Number (if known): _ KO83733
Device Name: Lume 2 Intense Pulsed Light & Laser System and delivery devices
Indications for Use:
The Lume 2, with Intense Pulsed Light ( IPL) wavelengths 515-1200 nm, is indicated for the treatment of:
Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) and tattoos.
Cutaneous lesions, including warts, scars and striae.
Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, and
For the removal of unwanted hair from all skin types, an to effect stable long term, or permanent1 hair reduction in skin types 1-V through selective targeting of melanin in hair follicles.
with Nd: YAG laser at wavelength 1064 nm, is indicated for:
The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment and clearance of superficial and deep telangiectasias) and reticular veins (0.1- 4.0 mm. diameter) of the leg
The removal of unwanted hair from all skin types, an to effect stable long term, or permanent' hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The non-ablative treatment of facial wrinkles.
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (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)
-Neil R. Ogden Firmxm
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083733
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