(135 days)
No
The document describes a system that delivers light, laser, and RF energy for various dermatological and surgical applications. There is no mention of AI, ML, image processing, or any other technology that would typically indicate the presence of AI/ML. The device description focuses on hardware components and energy delivery methods.
Yes
The device is indicated for various treatments of medical conditions and for surgical applications, which are therapeutic uses.
No
The device is indicated for treatment (e.g., treatment of lesions, hair removal, wrinkle treatment), not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a system console, control and display, delivery handpieces, skin cooling technology, trigger buttons, and a remote interlock connector. This indicates it is a hardware-based medical device with potentially integrated software, not a software-only device.
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" involving the delivery of light, laser, and RF energy for treating various skin conditions, removing hair, and treating wrinkles. This involves direct interaction with the patient's body for therapeutic or cosmetic purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
- Device Description: The device description details a system console, handpieces, cooling technology, and safety features, all consistent with a medical device used for external treatments.
- Lack of IVD-related information: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, the Lumenis One Family of Systems is a therapeutic and cosmetic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows:
Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm):
The 515-1200 nm intense pulsed light wavelengths are indicated for:
- The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- The treatment of tattoos;
- 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 telangiers poss 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 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:
- 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 non-ablative treatment of facial wrinkles.
LightSheer Diode Laser Wavelength (800 mm):
The 800 nm wavelength produced by the LightSheer diode laser is indicated for:
- The removal of unwanted hair, and to effect stable long-term, or permanent, hair reduction through selective targeting of melanin in hair follicles:
- The treatment of vascular lesions, including angiomas, hemangiomas telangiectasia and other benign vascular lesions;
- The treatment of leg veins;
- The treatment of benign pigmented lesion;
- The treatment of pseudofolliculitis barbae;
The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types 1 - VI), including tanned skin.
Aluma RF Energy (468 kHz):
The Aluma 468 kHz energy is indicated for:
- The Aluma Skin Renewal System is intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of wrinkles and thytids.
Product codes
GEX
Device Description
Lumenis One systems are comprised of the following main components:
- System console;
- Control and Display;
- One or more delivery handpieces, the Treatment Heads (up to three attached out of four handpieces available for each system);
- Skin cooling technology integrated into the handpiece (as applicable);
- Trigger button integrated into the handpiece; an additional safety button integrated into the laser handpieces;
- Remote interlock connector (disables pulse emission 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
Benign pigmented epidermal lesions, tattoos, cutaneous lesions (warts, scars, striae), benign cutaneous vascular lesions (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), facial wrinkles, vascular lesions (angiomas, hemangiomas telangiectasia and other benign vascular lesions), leg veins, benign pigmented lesion, pseudofolliculitis barbae.
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)
The Lumenis One Family of Systems share the same indications for use and the same or similar technical specifications as the currently marketed predicate Lumenis Family of Intense Pulsed-Light (IPL) and IPL Nd: Y AG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214). The small differences that exist in certain technical specifications are not significant and they do not alter the safety or effectiveness of the Lumenis One Family of Systems. Clinical data therefore was not provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K020839, K024093, K030342, K030527, K973324, K974346, K982940, K001746, K003614, K051214
Reference Device(s)
Not Found
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.
0
Section 5 510(k) Summary for the Lumenis One Family of Systems -
Lumenis, Inc.
I. General Information
Submitter:
Contact Person:
2400 Condensa Street Santa Clara, CA 95051
Connie Hoy Vice President, Global RA/QA
Lisa Scott Manager, RA/QA
June 30, 2006 Summary Preparation Date:
- II. Names
Device Names: Lumenis One Family of Systems; Lumemis One
Primary Classification Name: Laser Powered Surgical Instrument (and Accessories)
III. Predicate Devices
- Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: YAG Laser � Systems (K020839, K024093, K030342, K030527);
- LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, . K001746, K003614);
- . Aluma Skin Renewal System (K051214);
IV. Product Description
Lumenis One systems are comprised of the following main components:
- System console; �
- . Control and Display;
- One or more delivery handpieces, the Treatment Heads (up to three attached . out of four handpieces available for each system);
- Skin cooling technology integrated into the handpiece (as applicable); .
- Trigger button integrated into the handpiece; an additional safety button . integrated into the laser handpieces;
- . Remote interlock connector (disables pulse emission when treatment room door is opened).
V. Indications for Use
The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or RF energy) is indicated for use in surgical. aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows:
510(k) Submission: Lumenis One Family of Systems
1
> Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm):
The 515-1200 nm intense pulsed light wavelengths are indicated for:
- The treatment of benign pigmented epidermal lesions, including . dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- . The treatment of tattoos:
- 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 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 t (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 follicies;
- . The non-ablative treatment of facial wrinkles.
> LightSheer Diode Laser Wavelength (800 mm):
The 800 nm wavelength produced by the LightSheer diode laser is indicated for:
- The removal of unwanted hair, and to effect stable long-term, or 0 permanent', hair reduction through selective targeting of melani, in hair follicles;
- The treatment of vascular lesions, including angiomas, hemangiomas � telangiectasia and other benign vascular lesions;
- The treatment of leg veins; .
- The treatment of benign pigmented lesion; .
- The treatment of pseudofolliculitis barbae; .
The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types 1 - VI), including tanned skin.
510(k) Submission: Lumenis One Family of Systems
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
2
> Aluma RF Energy (468 kHz):
The Aluma 468 kHz energy is indicated for:
- The Aluma Skin Renewal System is intended for use in Dermatologic and General . Surgical procedures for the non-invasive treatment of wrinkles and thytids.
VI. Rationale for Substantial Equivalence
The Lumenis One Family of Systems share the same intended uses as the predicate devices-the Lumenis Family of Intense Pulsed-Light (IPL) and IPL Nd: Y A G Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214), in that they are intended for use for the same surgical, aesthetic and cosmetic applications in general and plastic surgery, and dermatology.
The Lumenis One Family of Systems share indications for use as the predicate devices.
The technical specifications, including the range of treatment parameters, the basic control system, and delivery devices of the Lumenis One Family of Systems are identical or similar to the predicate devices.
VII. Safety and Effectiveness Information
The Lumenis One Family of Systems share the same indications for use and the same or similar technical specifications as the currently marketed predicate Lumenis Family of Intense Pulsed-Light (IPL) and IPL Nd: Y AG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346, K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214). The small differences that exist in certain technical specifications are not significant and they do not alter the safety or effectiveness of the Lumenis One Family of Systems. Clinical data therefore was not provided.
VIII. Conclusion
Based on the foregoing, the Lumenis One Family of Systems were found to be substantially equivalent to the predicate devices, Lumenis Family of Intense Pulsed-Light (IPL) and IPL/Nd: Y AG Laser Systems (K020839, K024093, K030342, K030527), the LightSheer Pulsed Diode Array Laser System (K973324, K974346. K982940, K001746, K003614), and the Aluma Skin Renewal System (K051214 ), all marketed by Lumenis.
The Lumenis One Family of Systems share indications for use and similar or identical design features, functional features, and technical specifications, and thus are substantially equivalent to, the currently marketed predicate devices.
510(k) Submission: Lumenis One Family of Systems
Section 5 - Page 3
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which consists of three stylized human profiles facing to the right, with flowing lines representing hair or clothing. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is written around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL - 5 2006
Lumenis, Inc. c/o Ms. Martha Murari 2400 Condensa Street Santa Clara, California 95051
Re: K060448 Trade/Device Name: Lumenis One Family of Systems 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: May 16, 2006 Received: May 17, 2006
Dear Ms. Martha Murari:
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 ciassified (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. Martha Murari
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 (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtained, other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html .
Sincerely yours,
Herbert Leuer wo
for
Mark Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K060448
Device Name: Lumenis One Family of Systems
Indications for Use:
The Lumenis One Family of Systems (and the delivery accessories that are used with them to deliver light and/or laser and/or RF energy) is indicated for use in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology as follows:
> Intense Pulsed Light (IPL) Wavelengths (515 - 1200 nm):
The 515-1200 nm intense pulsed light wavelengths are indicated for:
- The treatment of benign pigmented epidermal lesions, including . dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- � The treatment of tattoos;
- 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 telangiers poss 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 through selective targeting of melanin in hair follicles.
*** Continued on Following Page***
| Prescription Use | ☑ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | ☐ |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| (Division Sign-Off) |
|---|
| --------------------- |
| Division of General, Restorative, | Page 1 of 2 |
|---|---|
| and Neurological Devices |
1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regimen.
| 510(k) Number | K060448 |
|---|---|
| --------------- | --------- |
6
> 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:
- 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 non-ablative treatment of facial wrinkles. .
> LightSheer Diode Laser Wavelength (800 nm):
The 800 nm wavelength produced by the LightSheer diode laser is indicated for:
- The removal of unwanted hair, and to effect stable long-term, or . permanent', hair reduction through selective targeting of melanin in hair follicles:
- The treatment of vascular lesions, including angiomas, hemangiomas . telangiectasia and other benign vascular lesions;
- The treatment of leg veins; .
- The treatment of benign pigmented lesion; .
The treatment of pseudofolliculitis barbae; ●
The LightSheer diode laser is intended for use on all skin types (Fitzpatrick skin types 1 - VI), including tanned skin.
A Aluma RF Energy (468 kHz):
The Aluma 468 kHz energy is indicated for:
- The Aluma Skin Renewal System is intended for use in Dermatologic and General . Surgical procedures for the non-invasive treatment of wrinkles and thytids.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | ☒ |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
AND/OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | ☐ |
|---|---|
| ------------------------------------------------ | --------------------------------------------------------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 2 of 2 Division of Gener and Neurological 510(k) Number