(190 days)
No
The document describes a laser/IPL system and its intended uses, focusing on energy delivery and cooling. There is no mention of AI, ML, or any features that would typically involve such technologies for image analysis, treatment planning, or other functions.
Yes.
The device is indicated for various medical treatments and procedures in the specialties of general and plastic surgery, and dermatology, including the treatment of lesions, vascular conditions, hair removal, and the non-ablative treatment of facial wrinkles.
No
The device is indicated for treatment (e.g., hair removal, lesion treatment, wrinkle treatment) and cooling, not for diagnosing conditions.
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 more attached hand-piece(s), which may have integrated skin cooling components. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical, aesthetic, and cosmetic applications requiring selective photothermolysis and hemostasis of soft tissue. This involves direct interaction with the patient's body for treatment purposes.
- 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. This device does not perform such tests on samples.
- Device Description: The device description details a light/laser system console, control panel, and hand-pieces for delivering energy to the patient. This aligns with a therapeutic or surgical device, not a diagnostic one.
- Lack of Diagnostic Language: The document does not mention any diagnostic procedures, analysis of biological samples, or the detection of specific markers or conditions through testing.
The device is a therapeutic medical device used for various treatments on the skin and soft tissue.
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 intended 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.
The Lumenis Family of Intense Pulsed-Light (IPL) systems and combination 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):
- 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 permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles;
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
Nd:YAG Laser Wavelength (1064 nm):
-
- 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 coagulation and hemostasis of vascular lesions and soft tissue, including:
-
- The non-ablative treatment of facial wrinkles.
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, hyperand/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 (comma separated list FDA assigned to the subject device)
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; and *
-
- One or more 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
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)
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.
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
Traditional Pre-market Notification K024093 Additional Information March 13, 2003
JUN 1 9 2003
510(k) Summary
| Category: | Comments |
|---|---|
| Sponsor: | Lumenis, Inc. |
| 2400 Condensa Street | |
| Santa Clara, CA 95051 | |
| Correspondent: | Andrea L. Ruth, RAC |
| Senior Associate II, Regulatory Affairs | |
| Contact Numbers: | 408.764.3235 |
| Device Common Name | Laser Powered Surgical Instrument (and Accessories) |
| Device Proprietary Name | Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems |
| Device Classification Name | Laser Surgical Instrument for Use in General and planstic |
| Surgery and in Dermatology | |
| Device Classification | 21 CFR § 878.4810 |
| Predicate Devices | IPL Quantum Family; VascuLight Family; Lyra™; GentleYAG™ |
| Predicate Device | |
| Manufacturer(s) | Lumenis; Lumenis; LaserScope; Candela |
| Predicate Device Reference(s) | K020839; K020839; K020021; K022951 |
| Predicate Device Classification | |
| Name(s) | Laser Surgical Instrument for Use in General and Plastic Surgery |
| and in Dermatology | |
| Predicate Device | |
| Classification(s) | 21 CFR §878.4810 |
Table 1 - Administrative Information
Date Summary Was Prepared: March 13, 2003.
Description of the Device: 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; and *
-
- One or more attached hand-piece(s), which may have integrated skin cooling components.
Intended 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 intended 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.
1
KOJ4093 1/2
Traditional Pre-market Notification K024093 Additional Information March 13, 2003
| Predicate Device | This device | Lumenis VascuLight
or IPL Quantum Families | Laserscope Lyra™ | Candela
GentleYAG |
|---------------------------|------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------|--------------------------------------------------|
| 510(k)
Reference | Current
submission | K020839 | K020021 | K022951 |
| Intended Use | Photocoagulation,
photothermolysis
and hemostsis
See indications for
use statement | Photocoagulation,
photothermolysis and
hemostsis | Treatment of facial
wrinkles | Treatment of
facial wrinkles |
| Device
Description | IPL and
IPL/Nd:YAG
combination | Same | Nd:YAG | Nd:YAG |
| Output Energy
Used | Coherent and non-
coherent light | Same | Same | Same |
| Energy
Configuration | 515 - 1200 nm
1064nm | Same | 1064 nm | 1064 nm |
| Fluence | Up to 150 J/cm² | Same | Up to 250 J/cm² | 10 to 70 J/cm² |
| Pulse | 2 to 16 ms
(to 48 ms triple
pulsed) | Same | 10 to 50 ms | 3 ms |
| Pulse Rate | 0.33 Hz | Same | 1-10 pps | 1 Hz |
| Spot Size | 6mm | Same | 3mm, 5mm,
10mm | 12 mm |
| Beam Delivery | Cooling Hand-
piece | Same | Fiber w/cooling
aiming beam
sapphire crystal | Lens-coupled
optical fiber with
hand-piece |
| Electricity | 115/230V | Same | 115/230V | 230V |
| Simultaneous
Delivery? | No | No | No | No |
| Single Use? | No | No | No | No |
| Sterilized? | No | No | No | No |
| Manufacturer | Lumenis | Lumenis | LaserScope | Candela |
| Device
Classification | II; 21 CFR §
878.4810, GEX | II; 21 CFR §
878.4810, GEX | II; 21 CFR §
878.4810, GEX | II; 21 CFR §
878.4810, GEX |
Table 2 - Comparison to Predicate Devices:
Summary of the Clinical Data: 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.
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with flowing lines, representing the department's mission related to health and human well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2003
Ms. Andrea L. Ruth, RAC Regulatory Affairs Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051
Re: K024093 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: March 13, 2003 Received: March 21, 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.
3
Page 2 - Ms. Andrea L. Ruth, RAC
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
4
Attachment 2 Indications for Use Statement as Requested by FDA
510(k) Number (if Known): K024093
of Intense Pulsed-Light Device Name: Lumenis Family (IPL) Systems & Combination IPL / Nd:YAG Systems and the Real Time Chiller
Indications For Use:
The Lumenis Family of Intense Pulsed-Light (IPL) systems and combination 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):
- 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 permanent1, hair reduction in skin types I-VI through selective targeting of melanin in hair follicles;
1 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)
OR
Over-The-Counter Use (Optional Format 1-2-96)
LUMENIS, INC. MODIFIED IPL AND IPLAND: YAG COMBINATION PRODUCT FAMILIES
5
510(k) Number (if Known):
Device Name: Lumenis Family of Intense Pulsed-Light (IPL) Systems & Combination IPL / Nd:YAG Systems and the Real Time Chiller
Indications For Use: *** Continued from Previous Page ***
Nd:YAG Laser Wavelength (1064 nm):
-
- 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 coagulation and hemostasis of vascular lesions and soft tissue, including:
-
- The non-ablative treatment of facial wrinkles.
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, hyperand/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 |
|---|---|
| Miriam C. Provost | |
| Division Sign-Off (Optional Format 1-2-96) |
eral, Restorative
LUMENIS, INC.
CONFIDENTIAL.
THE AND IPL/ND:YAG COMBINATION PRODUCT FAMILIES
CONFIDENTIAL
510(k) Number K 624093