(82 days)
Not Found
No
The document describes a laser/light system with various wavelengths and indications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The device description focuses on the hardware and delivery of thermal energy.
Yes.
The device is indicated for various therapeutic uses, including coagulation and hemostasis of vascular lesions, treatment of facial wrinkles, incision/excision of soft tissue in surgical applications, treatment of fine lines and wrinkles, treatment of acne and acne scars, and treatment of venous reflux and varicosities. The Pulsed Light indications also include therapeutic uses such as topical heating for pain relief and increased circulation.
No
Explanation: The device is indicated for various therapeutic and cosmetic applications, such as coagulation, hair reduction, treatment of wrinkles, and soft tissue incision/excision. It is not designed to diagnose diseases or conditions.
No
The device description clearly states it is a "modular, multi-wavelength laser/light system" consisting of a "control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner." This indicates significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to treating conditions and performing surgical procedures on the human body (coagulation, hair removal, wrinkle treatment, soft tissue cutting, lipolysis, vein treatment, skin resurfacing, treatment of lesions, pain relief). IVDs are used to diagnose diseases or conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The device is described as a laser/light system that delivers thermal energy to a treatment site. This is consistent with a therapeutic device, not a diagnostic one.
- Anatomical Site: The anatomical sites listed are all parts of the living body where treatment is applied. IVDs work with samples from these sites, not directly on them.
- No mention of analyzing samples: There is no mention of the device analyzing biological samples or providing diagnostic information.
The device is clearly a therapeutic device used for various medical and cosmetic treatments.
N/A
Intended Use / Indications for Use
1064 nm Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to-telangiectasia and rosacea. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis.
1320 nm Indications for Use: It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris. Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.
2940 nm Indications for Use; Skin resurfacing and treatment of wrinkles.
Pulsed Light (300-1400 nm) Indications for Use: The Profile Multi-Platform Systems and Accessories 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. It is intended for use for. The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter) The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiornas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter) The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction: (590nm LP filter, 640nm LP filter, 695nm LP filter) Treatment of facial wrinkles, treatment of fine lines and wrinkles; and (590nm LP filter, 640nm LP filter, 695nm LP filter, 800nm LP filter) Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter)
Product codes
GEX
Device Description
The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands, facial, truncal, leg
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)
Not Found
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.
K060033: Profile Multi-Platform Laser System and Accessories, K062321: Cynosure SmartLipo Nd:YAG Laser System, K062822, K051287: Vascular Solutions Vari-Lase Lasers, K062210, K061618: CoolTouch CTEV Nd:YAG Laser Systems, K023954: Altus Medical CoolGlide Aesthetic Lasers, K003715: CoolTouch Nd:YAG Laser System, K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems, K053616, K031671: Polaris WR, ST Applicator, K0041242: Candela Smoothbeam Laser, K051255: Opusmed LumiPhase-R, K031425: Light BioScience GentleWaves LED Photomodulation Device, K042165: Cutera Titan Tabletop Product, K042630: RevLight Skin Care System
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
Attachment IV
510(k) Summary
MAY - 2 2007
:
.
| Submitter | Sciton, Inc. |
|---|---|
| Address: | 925 Commercial Street, Palo Alto, CA 94303 |
| Phone: | (650) 493-9155 |
| Fax : | (650) 493-9146 |
| Contact Person: | Jay M. Patel, VP of Regulatory Affairs |
| Date Prepared: | April 10, 2007 |
| Device Trade Name: | Profile Multi-Platform System |
| Common Name: | Laser/Light Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally Marketed | |
| Predicate Device: | K060033: Profile Multi-Platform Laser System and Accessories |
| K062321: Cynosure SmartLipo Nd:YAG Laser System | |
| K062822, K051287: Vascular Solutions Vari-Lase Lasers | |
| K062210, K061618: CoolTouch CTEV Nd:YAG Laser Systems | |
| K023954: Altus Medical CoolGlide Aesthetic Lasers | |
| K003715: CoolTouch Nd:YAG Laser System | |
| K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems | |
| K053616, K031671: Polaris WR, ST Applicator | |
| K0041242: Candela Smoothbeam Laser | |
| K051255: Opusmed LumiPhase-R | |
| K031425: Light BioScience GentleWaves LED Photomodulation Device | |
| K042165: Cutera Titan Tabletop Product | |
| K042630: RevLight Skin Care System | |
| Description of | |
| Profile Multi-Platform | |
| System | The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. |
| The system uses scanning and focusing optics to deliver a pattern of thermal | |
| energy to the treatment site. The system consists of control console which houses the | |
| power supply, cooling system, fiber optic delivery system and/or articulated arm | |
| delivery system with handpiece and/or scanner. | |
| Intended Use: | 1064 nm Indications for Use: |
| Coagulation and hemostasis of benign vascular lesions such as, but not limited | |
| to-telangiectasia and rosacea. | |
| Removal of unwanted hair, for the stable long term, or permanent hair | |
| reduction through selective targeting of melanin in hair follicles, and for | |
| the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser | |
| Systems and Accessories are indicated for use on all skin types | |
| (Fitzpatrick I-VI), including tanned skin. | |
| The Profile 1064 Laser Systems and Accessories are indicated for the | |
| treatment of facial wrinkles. | |
| Incision/excision and cutting, vaporization, ablation, | |
| coagulation/hemostasis of soft tissue in the performance of surgical | |
| applications. All soft tissue is included, such as skin, cutaneous tissue, | |
| subcutaneous tissue, striated and smooth tissue, muscle, cartilage | |
| meniscus, mucous membrane, lymph vessels and nodes, organs and | |
| glands. It is further indicated for laser assisted lipolysis. |
:
1
1320 nm Indications for Use:
It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.
Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.
2940 nm Indications for Use;
Skin resurfacing and treatment of wrinkles.
Pulsed Light (300-1400 nm) Indications for Use:
The Profile Multi-Platform Systems and Accessories 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.
It is intended for use for.
- · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter)
- · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiornas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter)
- · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction: (590nm LP filter, 640nm LP filter, 695nm LP filter)
- · Treatment of facial wrinkles, treatment of fine lines and wrinkles; and (590nm LP filter, 640nm LP filter, 695nm LP filter, 800nm LP filter)
- · Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter)
| Technological
Characteristics | The Profile Multi-Platform System shares the same indications for use, similar design
features (including wavelength, laser/light medium and delivery systems, power
supply, cooling and control system), functional features (including power output,
repetition rate, energy, spot size and fluence), and is therefore substantially
equivalent to the above legally marketed predicate devices. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Effectiveness | The indications for use are based upon the indications for use for predicate systems.
Technologically, the Profile Multi-Platform System is substantially equivalent to the
listed predicate devices. Therefore, the risks and benefits for the Profile Multi-Platform
System are comparable to the predicate devices. |
| Conclusion | The Profile Multi-Platform System shares similar indications for use, design features,
and similar functional features as, and therefore is substantially equivalent to, the
currently marketed predicate devices. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2008
Sciton, Inc % Mr. Jav M. Patel 925 Commercial Street Palo Alto, California 94303
Re: K070388
Trade/Device Name: Profile Multi-Platform System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery in dermatology Regulatory Class: II Product Code: GEX Dated: February 8, 2007 Received: February 13, 2007
Dear Mr. Patel:
This letter corrects our substantially equivalent letter of May 2, 2007.
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 (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 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 - Mr. Jay M. Patel
This letter will allow you to continue 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 obtain 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/dsma/dsmamain.html
Sincerely yours.
Neil R.E. Ogden
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Attachment III
Statement of Indications for Use
| 510(k) Number (if known): | K070388 |
|---|---|
| --------------------------- | --------- |
Profile Multi-Platform System Device Name:
Indications for Use:
1064 nm Indications for Use:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to telangiectasia and rosacea.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial winkles.
Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis.
1320 nm Indications for Use:
It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.
Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.
2940 nm Indications for Use:
Skin resurfacing and treatment of wrinkles.
| Prescription Use
| (Per 21CFR801) | X |
|---|---|
| OR Over-The-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 2
1 of 2
510(k) Number K070388
5
Pulsed Light (300-1400 nm) Indications for Use:
The Profile Multi-Platform Systems and Accessories 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. It is intended for use for:
- · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter)
- · 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;
- (560nm LP filter, 590nm LP filter)
- · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
- (590nm LP filter, 640nm LP filter, 695nm LP filter)
- · Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter)
Nil R.P. Ogle
(Division Sign-Off) for mxm
Division of General, Restorative, and Neurological Devices
510(k) Number K070388