(164 days)
Not Found
No
The document describes a laser and IPL system with a cooling component. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, diagnosis, or treatment planning. The device description focuses on hardware components and the intended use is based on the physical properties of light and laser energy.
Yes
The device is used for medical treatments such as the treatment of vascular lesions, pigmented lesions, warts, scars, and hair removal. The Real Time Chiller component is specifically indicated to reduce pain and discomfort, and minimize thermal injury during treatment, which directly relates to therapeutic effects.
No
The document specifies the device's use for surgical, aesthetic, and cosmetic applications involving selective photothermolysis and hemostasis, such as treating lesions, removing hair, and coagulating vascular tissues. These are therapeutic and aesthetic actions, not diagnostic ones.
No
The device description explicitly states it is comprised of a light/laser system console (including software and control electronics), a control and display panel, and one or two attached hand-piece(s), which are all hardware components. While it includes software, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device uses Intense Pulsed Light and Nd:YAG laser energy to directly treat various conditions on the human body (skin, hair follicles, vascular lesions, etc.). It is a therapeutic device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use is for surgical, aesthetic, and cosmetic applications requiring selective photothermolysis and hemostasis of soft tissue. This involves direct treatment of the patient.
- Device Description: The components described (light/laser system console, hand-piece, chiller) are consistent with a therapeutic light/laser system, not an IVD.
The device is a therapeutic medical device used for direct treatment of patients, not for analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd: YAG laser systems (and the delivery accessories that are used with them to deliver light and/ or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm) are indicated for:
- The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae;
- The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melsma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent^3, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm) is indicated for the coagulation and hemostasis of vascular lesions and soft tissue, including:
- Treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm diameter) of the leg.
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent^3, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
- Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);
- Reduce discomfort during and/or associated with light or laser treatment;
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper and/or hypopigmentation;
- Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
- Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).
Product codes
GEX
Device Description
Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd:YAG laser systems are comprised of the following main components:
- A light/laser system console (including software and control electronics);
- A control and display panel;
- One or two attached hand-piece(s), which may have integrated skin cooling components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, epidermis, leg.
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)
Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology.
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
Summary
KC30342 1/3
JUL 17 2003
| Submitter: | Lumenis, Inc.
2400 Condensa Street
Santa Clara, CA 95051 |
|------------------------------|------------------------------------------------------------------------------|
| Contact Person: | Andrea L. Ruth,
Senior Associate, Regulatory Affairs |
| Summary Preparation Date: | January 31, 2003 |
| Names | |
| Device Names: | Lumenis Family of Intense Pulsed-Light (IPL) and
IPL/Nd:YAG Laser Systems |
| Primary Classification Name: | Laser Powered Surgical Instrument (and Accessories) |
Product Description III.
General Information
I.
II.
Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd:YAG laser systems are comprised of the following main components:
- A light/laser system console (including software and control electronics); *
-
- A control and display panel;
- One or two attached hand-piece(s), which may have integrated skin cooling * components.
IV. Indications for Use
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: YAG laser systems (and the delivery accessories that are used with them to deliver light and/or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology.
Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm) are indicated for:
- The treatment of tattoos and benign pigmented epidermal and cutaneous lesions * including warts, scars and striae;
1
- The treatment of benign cutaneous vascular lesions, including port wine stains, * hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable long-term, or * permanent2, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm) is indicated for the coagulation and hemostasis of vascular lesions and soft tissue, including:
- Treatment and clearance of superficial and deep telangiectasias (venulectasias) and * reticular veins (0.1 - 4.0 mm diameter) of the leg.
- The removal of unwanted hair from all skin types, and to effect stable long-term, * or permanent2, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
- Reduce pain during and/or associated with light or laser treatment (via partial * anesthesia from cooling);
-
- Reduce discomfort during and/or associated with light or laser treatment;
-
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing hyperand/or complications such as scabbing, scarring, possible hypopigmentation;
- Allow the use of higher light or laser fluences for light or laser treatments (such as * for hair removal and the treatment of vascular or pigmented lesions); and
- Reduce potential side effects of light or laser treatments (such as for hair removal * and the treatment of vascular or pigmented lesions).
V. Rationale for Substantial Equivalence
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: Y AG laser systems share the same general indications for use, and therefore is substantially equivalent for use in surgical, aesthetic and cosmetic applications to the previously cleared IPL and IPL/Nd:YAG family.
VI. Safety and Effectiveness Information
Clinical data was provided to demonstrate that the Lumenis Family of IPL and IPL/Nd:YAG laser (1064 nm) systems are safe and effective, when indicated in
2 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
2
Ko 30342 >/ 3
specific applications in the medical specialties of general and plastic surgery, and dermatology.
VII. Conclusion
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems were shown to be substantially equivalent to the predicate devices cleared in K020839. The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems has identical intended use, as well as functional and design features as the currently marketed predicate devices. The only change is expansion of labeled indications for use, which fall within the scope of the intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
JUL 17 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Andrea L. Ruth Senior Associate, Regulatory Affairs Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051
Re: K030342 Trade/Device Name: Lumenis Family of Intense Pulsed-Light (IPL) and IPL/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: May 12, 2003 Received: May 13, 2003
Dear Ms. Ruth:
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 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.
4
Page 2 - Ms. Andrea L. Ruth
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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 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
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
5
K630342 510(k) Number (if Known):
Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Device Name: Laser Systems
Indications For Use:
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/ Nd: YAG laser systems (and the delivery accessories that are used with them to deliver light and/ or laser energy) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology as follows:
Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm) are indicated for:
-
- The treatment of tattoos and benign pigmented epidermal and cutaneous lesions including warts, scars and striae;
- The treatment of benign cutaneous vascular lesions, including port wine stains, * hemangiomas, facial, truncal and leg telangiectasias, rosacea, melsma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- The removal of unwanted hair from all skin types, and to effect stable long-term, or * permanent3, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
Nd:YAG Laser Wavelength (1064 nm) is indicated for the coagulation and hemostasis of vascular lesions and soft tissue, including:
- Treatment and clearance of superficial and deep telangiectasias (venulectasias) and * reticular veins (0.1 - 4.0 mm diameter) of the leg.
-
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent3, hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
*** Continued on Following Page ***
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
3 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
LUMENIS, INC. MODIFICATION TO IPL AND IPL/ND:YAG COMBINATION PRODUCT FAMILIES CONFIDENTIAL
6
510(k) Number (if Known):
Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Device Name: Laser Systems
*** Continued from Previous Page ***
The Real Time Chiller is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
- Reduce pain during and/or associated with light or laser treatment (via partial * anesthesia from cooling);
- Reduce discomfort during and/or associated with light or laser treatment; 关
-
- Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper and/or hypopigmentation;
- Allow the use of higher light or laser fluences for light or laser treatments (such as * for hair removal and the treatment of vascular or pigmented lesions); and
- Reduce potential side effects of light or laser treatments (such as for hair removal * and the treatment of vascular or pigmented lesions).
Muriam C. Provost
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Image /page/6/Picture/14 description: The image shows a simple line drawing. The drawing consists of a horizontal line at the bottom, with a diagonal line extending upwards and to the left from the left end of the horizontal line. The diagonal line appears to be part of a larger shape or design, but the rest of the image is not visible.
Over-The-Counter Use OR
(Optional Format 1-2-96)
(Per 21 CFR 801.109)
LUMENIS, INC. MODIFICATION TO IPL AND IPL/ND:YAG COMBINATION PRODUCT FAMILIES CONFIDENTIAL