(210 days)
No
The summary describes a laser and IPL system with a cooling device. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on clinical safety and effectiveness and cooling device performance, not AI/ML model validation.
Yes
The device is indicated for various medical treatments, including the treatment of tattoos, benign pigmented lesions, vascular lesions, and for permanent hair reduction. These are all therapeutic applications.
No
The device is indicated for treatment (therapeutic) applications such as the treatment of tattoos, lesions, unwanted hair, and coagulation/hemostasis, rather than for diagnosing conditions.
No
The device description explicitly states it is comprised of hardware components such as a light/laser system console, handpiece(s), and a skin cooling device, in addition to software.
Based on the provided information, this device 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.
- Device Function: The description clearly states that this device is a laser and intense pulsed light system used for surgical, aesthetic, and cosmetic applications directly on the patient's body (soft tissue, skin, hair follicles). It uses light and laser energy to treat various conditions.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the body. Its function is to deliver energy to the body.
Therefore, this device falls under the category of therapeutic or surgical devices, not in vitro diagnostics.
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) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems is indicated for the treatment of tattoos and benign pigmented epidermal and cutaneous lesions, including warts, scars and striae, and the treatment of 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 the removal of unwanted hair from all skin types, and to effect stable long-term, or permanent , hair reduction in skin types I-V through selective targeting of melanin in hair follicles (515 - 1200 nm), and for the coagulation and hemostasis of vascular lesions and soft tissue (1064 nm).
In addition, the Lumenis Family of IPL/Nd:YAG laser systems (1064 nm) is safe and effective when indicated for coagulation and hemostasis of vascular lesions and soft tissue, including, the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm diameter) of the leg.
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), to reduce discomfort during and/or associated with light or laser treatment, to 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, to 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). to reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions), and to protect the skin from thermal necrosis, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation.
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 handpiece(s);
- A skin cooling device integrated into the handpiece (on some handpieces);
- A trigger button integrated into the handpiece;
- . A remote interlock connector (disables light/laser when treatment room door is opened).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, tattoos, benign pigmented epidermal and cutaneous lesions, warts, scars and striae, benign cutaneous vascular lesions, port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations, unwanted hair from all skin types, hair follicles, superficial and deep telangiectasias (venulectasias) and reticular veins of the leg, epidermis.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
General and plastic surgery, and dermatology.
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/Nd: YAG laser systems (1064 nm) are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology. Performance data was provided to demonstrate that the Cooling Head integrated into the Treatment Head of the delivery handpiece for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems operates in accordance with its specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K991935, K994014, K994014, K991935, K980537, K960772, K950493
Reference Device(s)
K011092, K001589, K951033, K000503, K990417, K960032
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.
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K020839 1/3
Attachment 25 OCT 11 2002 510(k) Summary Statement for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: YAG Laser Systems
I. General Information
| Submitter: | Lumenis, Inc.
2400 Condensa Street
Santa Clara, CA 95051 |
|---------------------------|----------------------------------------------------------------|
| Contact Person: | Anne C Worden
Acting VP, Regulatory & QA |
| Summary Preparation Date: | March 11, 2002 |
II. 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) |
III. Predicate Devices
- ESC Medical Systems EpiLight (K991935, K994014); .
- ESC Medical Systems MultiLight (K994014); ●
- ESC Medical Systems Photoderm HR (K991935); ●
- ESC Photoderm Nd: YAG Accessory (K980537); ●
- ESC Photoderm PL (K960772); ●
- ESC Photoderm VL (K950493);
- . Candela SPTL-1e Pulsed Dye laser system (K011092);
- . Candela Dynamic Cooling Devices (K001589, K951033);
- MedArt 520 Cooling System (K000503);
- OptoMed DermaCool Skin Cooling Device (K990417); and ●
- Coherent Epidermal Chiller Tip (K960032).
IV. Product 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 handpiece(s);
- A skin cooling device integrated into the handpiece (on some handpieces);
- A trigger button integrated into the handpiece;
- . A remote interlock connector (disables light/laser when treatment room door is opened).
1
020839 2/3
V. 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) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems is indicated for the treatment of tattoos and benign pigmented epidermal and cutaneous lesions, including warts, scars and striae, and the treatment of 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 the removal of unwanted hair from all skin types, and to effect stable long-term, or permanent , hair reduction in skin types I-V through selective targeting of melanin in hair follicles (515 - 1200 nm), and for the coagulation and hemostasis of vascular lesions and soft tissue (1064 nm).
In addition, the Lumenis Family of IPL/Nd:YAG laser systems (1064 nm) is safe and effective when indicated for coagulation and hemostasis of vascular lesions and soft tissue, including, the treatment and clearance of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1-4.0 mm diameter) of the leg.
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), to reduce discomfort during and/or associated with light or laser treatment, to 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, to 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). to reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions), and to protect the skin from thermal necrosis, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation.
VI. Rationale for Substantial Equivalence
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems share the same general indications for use, and therefore is substantially equivalent for use in surgical, aesthetic and cosmetic applications to the ESC Medical Systems EpiLight intense pulsed light systems (K991935, K994014), the ESC Medical Systems MultiLight intense pulsed light systems (K994014), the ESC Medical Systems Photoderm HR intense pulsed light systems (K991935), the ESC Medical Systems Photoderm Nd:YAG Accessory (K980537), the ESC Medical Systems Photoderm PL intense pulsed light systems (K960772), the ESC Medical Systems Photoderm VL intense pulsed light system (K950493), the Candela SPTL-1e Pulsed Dye laser system (K011092), the Candela Dynamic Cooling Devices (K001589 & K951033), the MedArt 520 Cooling System (K000503), the OptoMed DermaCool System and Handpieces (K990417), and the Coherent Epidermal Chiller Tip (K960032). In addition, clinical data demonstrated that
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020839 3/3
the Lumenis Family of IPL/Nd:YAG laser systems (1064 nm) are safe and effective when indicated for use in specific applications in the medical specialties of general and plastic surgery, and dermatology.
VII. Safety and Effectiveness Information
Clinical data was provided to demonstrate that the Lumenis Family of IPL/Nd: YAG laser systems (1064 nm) are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology. Performance data was provided to demonstrate that the Cooling Head integrated into the Treatment Head of the delivery handpiece for the Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems operates in accordance with its specifications.
VIII. Conclusion
The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems were found to be substantially equivalent to the predicate ESC Medical Systems EpiLight intense pulsed light systems (K991935, K994014), the ESC Medical Systems MultiLight intense pulsed light systems (K994014), the ESC Medical Systems Photoderm HR intense pulsed light systems (K991935), the ESC Medical Systems Photoderm Nd:YAG Accessory (K980537), the ESC Medical Systems Photoderm PL intense pulsed light systems (K960772), the ESC Medical Systems Photoderm VL intense pulsed light system (K950493), the Candela SPTL-1e Pulsed Dye laser system (K011092), the Candela Dynamic Cooling Devices (K001589 & K951033), the MedArt 520 Cooling System (K000503), the OptoMed DermaCool System and Handpieces (K990417), and the Coherent Epidermal Chiller Tip (K960032). The Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems shares similar indications for use, design features, and similar functional features as, and thus are substantially equivalent to, the currently marketed predicate devices.
Clinical data was provided to demonstrate that the Lumenis Family of IPL/Nd: YAG laser systems (1064 mm) are safe and effective, when indicated in specific applications in the medical specialties of general and plastic surgery, and dermatology.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 11 2002
Ms. Anne C. Worden Acting Vice President, Regulatory and Quality Assurance Lumenis. Inc. 2400 Condensa Street Santa Clara, California 95051
Re: K020839
Trade/Device Name: Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems and the Real Time Chiller Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: July 11, 2002 Received: July 15, 2002
Dear Ms. Worden:
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 mav 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/3/Picture/11 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of an eagle, with its wings spread and head turned to the right.
4
Page 2 – Ms. Anne C. Worden
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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). 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,
Stupt Rworde
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
Attachment 2 Indications For Use Statement as Requested by FDA
510(k) Number (if Known): K020839
Device Name: Lumenis Family of Intense Pulsed-Light (IPL) Systems & Combination IPL Systems and Nd:YAG Laser Systems and the Real Time Chiller
Indications For Use:
ষ্ট
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:
-
A Intense Pulsed Light Energy/Wavelengths (515 - 1200 nm):
The 515 - 1200 nm intense pulsed light wavelengths 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, 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 permanent , hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
-
Nd:YAG Laser Wavelength (1064 nm):
The 1064 nm wavelength produced by the Nd: YAG laser 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.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
*** 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
| (Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
| Division Signe Officer Use | |
|---|---|
| Division of General, Restorative | |
| and Neurological Devices | |
| K020839 | (Optional Format 1-2-96) |
| 510(k) Submission: Lumenis Family 510(k) Number YAG Laser Systems | Attachment 2 - Page 1
Page revised |
| ------------------------------------------------------------------- | --------------------------------------- |
|---|
6
K020839 510(k) Number (if Known):
Device Name: Lumenis Family of Intense Pulsed-Light (IPL) Systems & Combination IPL
Systems and Nd: YAG Laser Systems and the Real Time Chiller
Continued from Previous Page Indications For Use:
> Real Time Chiller:
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).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
| (Division Sign-Off) | |
| Division of General, Restorative and Neurological Devices | |
| (Optional Format 1-2-96) | |
| 510(k) Number | K020839 |
510(k) Submission: Lumenis Fanily of IPL & IPL Nd: Y AG Laser Systems
Attachment 2 - Page 2 Page revised