(90 days)
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.
Intense Pulsed Light Energy / Wavelengths (515 - 1200 nm) are indicated for:
- The treatment of tattoos;
- The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides(freckles);
- The treatment of 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, erythema of rosacea, 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.
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, 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 complications such as scabbing, scarring, hyperand/or 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).
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.
Here's an analysis of the provided text, outlining the acceptance criteria and the study details based on the information given:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a table format. Instead, it concludes that the device is "safe and effective for their intended and indicated uses" and "substantially equivalent to the predicate devices." The performance claim is equivalency.
| Acceptance Criteria Category | Reported Device Performance (as inferred from the document) |
|---|---|
| Safety and Effectiveness | Demonstrated to be safe and effective for intended and indicated uses in general and plastic surgery, and dermatology. |
| Substantial Equivalence | Shown to be substantially equivalent to predicate devices cleared in K020839 (IPL Quantum Family; VascuLight Family). |
| Intended Use | Identical intended use as currently marketed predicate devices. |
| Functional and Design Features | Identical functional and design features as currently marketed predicate devices. |
| Expanded Indications | Expansion of labeled indications for use falls within the scope of the intended use, without compromising safety or effectiveness. |
2. Sample Size for Test Set and Data Provenance
- Sample Size: The document states that "Clinical data was provided," but it does not specify the sample size (number of patients or cases) used for the clinical evaluation.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It simply refers to "Clinical data."
3. Number of Experts and Qualifications for Ground Truth
The provided text does not mention the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). Since this is a laser and light system for dermatological and surgical applications, clinical outcomes would likely be assessed by treating physicians, but the document provides no details on this.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed.
- Effect size of human reader improvement with AI vs. without AI assistance: This is not applicable as an MRMC study was not described, and the device is a laser/light system, not an AI-assisted diagnostic tool for human readers.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone performance study done? This question is generally relevant for AI/ML algorithms. The device described, the "Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG laser systems," is a physical medical device that delivers energy for treatment. Therefore, the concept of a "standalone (algorithm only) without human-in-the-loop performance" study as typically understood for diagnostic AI does not directly apply in this context. The clinical data provided would assess the device's direct therapeutic efficacy and safety.
7. Type of Ground Truth Used
The document implies that the ground truth would be based on clinical outcomes observed in patients treated with the device, such as "selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue," "treatment of tattoos," "treatment of benign pigmented epidermal lesions," "removal of unwanted hair" etc. It is not expert consensus on images, pathology, or solely outcomes data, but rather a direct assessment of the device's therapeutic effects on the patient's condition.
8. Sample Size for the Training Set
This document describes a medical device (laser/light system) rather than a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI development does not apply to this submission. The device is evaluated through clinical trials for safety and effectiveness, not trained on data like an AI model.
9. How the Ground Truth for the Training Set Was Established
As explained in point 8, the concept of a "training set" is not applicable to this physical medical device. The "ground truth" for the device's performance would be established through established clinical endpoints and assessments during its clinical evaluation.
{0}------------------------------------------------
K0305627
MAY 2 0 2003
Appendix 2 VIII.
A. 510(k) Summary
Table 1 - Administrative Information
1/2
| Category: | Comments |
|---|---|
| Sponsor: | Lumenis, Inc.2400 Condensa StreetSanta Clara, CA 95051 |
| Correspondent: | Andrea L. Ruth, RACSenior 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:YAGLaser Systems |
| Device Classification Name | Laser Surgical Instrument for Use in General and plansticSurgery and in Dermatology |
| Device Classification | 21 CFR § 878.4810 |
| Predicate Devices | IPL Quantum Family; VascuLight Family |
| Predicate DeviceManufacturer(s) | Lumenis |
| Predicate Device Reference(s) | K020839 |
| Predicate Device ClassificationName(s) | Laser Surgical Instrument for Use in General and plansticSurgery and in Dermatology |
| Predicate DeviceClassification(s) | 21 CFR §878.4810 |
Date Summary Was Prepared: February 15, 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}------------------------------------------------
Kozo iji) 2/2
Traditional 510(k) Submission February 14, 2003
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 for their intended and indicated uses in the medical specialties of general and plastic surgery, and dermatology.
Conclusion: The Lumenis Family of Intense Pulsed-Light (IPL) and IPL / Nd: Y AG 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2003
Ms. Andrea L. Ruth, RAC Senior Associate II, Regulatory Affairs Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051
Re: K030527
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: February 14, 2003 Received: February 19, 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 (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.
{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,
Sincerely, yours,
Muh M. Milsener
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}------------------------------------------------
510(k) Number (if Known): K030527
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; 关
- The treatment of benign pigmented epidermal lesions including dyschromia, * hyperpigmentation, melasma, ephelides(freckles);
-
- The treatment of 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, erythema of rosacea, 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-V.
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) | |
|---|---|---|---|
| ------------------------------------------ | ----------------------------------------- | ----------------------------------------------------- | -- |
1 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
{5}------------------------------------------------
510(k) Number (if Known): K030527
Device Name:
Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd:YAG Laser Systems
*** Continued from Previous Page ***
JAII CHILIS INC
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 permanent1, 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 complications such as scabbing, scarring, hyperand/or 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).
(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. MODIFICATION TO IPL AND IPL/ND: YAG COMBINATION PRODUCT FAMILIES CONFIDENTIAL
§ 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.