(90 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the intended use, device description, or performance studies.
Yes
The device is intended for various medical treatments, including the treatment of skin lesions, vascular lesions, and hair removal, which are conditions that impact a patient's health or body structure.
No
The document explicitly states that the device is intended for "surgical, aesthetic and cosmetic applications requiring selective photothermolysis" and lists various treatments, such as hair removal, tattoo treatment, and lesion treatment. It does not mention any diagnostic functions.
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 are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "surgical, aesthetic and cosmetic applications requiring selective photothermolysis... of soft tissue". This involves direct treatment of the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This device does not perform such examinations.
- Device Description: The description details a light/laser system console, control panel, and hand-pieces, all designed for delivering energy to the body.
- Anatomical Site: The anatomical sites mentioned (soft tissue, epidermis, leg, hair follicles) are all parts of the living body being treated directly.
The device is a therapeutic device used for medical and cosmetic procedures, not for diagnostic testing of samples outside the body.
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) 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;
- 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).
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; 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
Skin, soft tissue, leg veins
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical specialties of general and plastic surgery, and dermatology. (Implied professional user in a clinical setting).
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 for their intended and indicated uses in the medical specialties of general and plastic surgery, and dermatology.
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 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
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 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 |
| Predicate Device | |
| Manufacturer(s) | Lumenis |
| Predicate Device Reference(s) | K020839 |
| Predicate Device Classification | |
| Name(s) | Laser Surgical Instrument for Use in General and planstic |
| Surgery and in Dermatology | |
| Predicate Device | |
| Classification(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