(94 days)
No
The summary describes a light-based therapy device with cooling capabilities and mentions an internal computer for control, but there is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is indicated for the treatment of various medical conditions such as tattoos, benign pigmented lesions, cutaneous lesions, benign cutaneous vascular lesions, psoriasis, vitiligo, atopic dermatitis, and seborrheic dermatitis. These are all therapeutic applications.
No
The device is indicated for use in surgical, aesthetic, and cosmetic applications for treating various skin conditions and for hair removal. Its function is to emit intense wide-spectrum emission to ablate or modify tissue (photothermolysis), not to diagnose conditions.
No
The device description explicitly states it consists of a system console, internal computer, control panel and display, and a treatment head with cooling capability and a pushbutton switch, indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the Profile BBL system clearly indicates it is a device that emits light and/or laser energy for direct treatment of soft tissue and skin. It is used for surgical, aesthetic, and cosmetic applications.
- Intended Use: The listed intended uses are all related to treating conditions directly on the patient's body (e.g., treating tattoos, lesions, vascular issues, hair removal). There is no mention of analyzing samples taken from the body.
The device is a therapeutic device that uses light and laser technology for direct treatment, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The Profile BBL (and the light and/or laser delivery accessories) is 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 tattoos;
- The treatment of benign pigmented 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, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction.
The integral thermo-electric cooler 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, hyper- and/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
GEX
Device Description
Profile BBL System emits intense wide spectrum emission with wavelength of 500-1400 nm. It consists of a system console, internal computer, control panel and display, and a treatment head comprised of a light guide with cooling capability and a pushbutton switch.
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
medical specialties of general and plastic surgery and dermatology.
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)
K030527, K020839, K020453, K023954
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
NOV 1 3 2003
Attachment IV
510(k) Summary
| Submitter: | Sciton, Inc. |
|---|---|
| Address: | 845 Commercial Street, Palo Alto, CA 94303 |
| Phone: | (650) 493-9155 |
| Fax : | (650) 493-9146 |
| Contact Person: | Jay M. Patel, Director of Regulatory Affairs |
| Date Prepared: | July 31, 2003 |
| Device Trade Name: | Profile BBL System |
| Common Name: | Laser Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally Marketed | |
| Predicate Device: | Lumenis Family of Intense Pulsed-Light (KO30527, |
| K020839) | |
| Palomar EsteLux (K020453) | |
| Altus Medical CoolGlide with Optional Pulsed Light Hand | |
| Piece (K023954) | |
| Description of | |
| Profile BBL System: | Profile BBL System emits intense wide spectrum |
| emission with wavelength of 500-1400 nm. It consists of a | |
| system console, internal computer, control panel and | |
| display, and a treatment head comprised of a light guide | |
| with cooling capability and a pushbutton switch. | |
| Intended Use: | The Profile BBL (and the light and/or laser delivery |
| accessories) is 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 tattoos; | |
| • The treatment of benign pigmented 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, engiomas | |
| and spider angiomas, poikiloderma of Civatte, leg veins and | |
| venous malformations; | |
| • Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), | |
| seborrheic dermatitis; and | |
| • The removal of unwanted hair from all skin types, and to | |
| effect stable long-term, or permanent, hair reduction. | |
| The integral thermo-electric cooler 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, hyper- and/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). | |
| Rationale for Substantial | |
| Equivalence: | The Profile BBL Laser System shares the same |
| indications for use, similar design features (including | |
| wavelength, laser medium, 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 | |
| Information | The indications for use are based upon the indications for |
| use for predicate systems. Technologically, the Profile BBL | |
| system is substantially equivalent to the listed predicate | |
| devices. Therefore, the risks and benefits for the Profile | |
| BBL system are comparable to the predicate devices. | |
| Conclusion | The Profile BBL shares similar indications for use, design |
| features, and similar functional features as, and therefore | |
| is substantially equivalent to, the currently marketed | |
| predicate devices. |
1
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus is depicted with three lines forming a shape resembling a bird or a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2003
Mr. Jay M. Patel Director of Regulatory Affairs Sciton, Inc. 845 Commercial Street Palo Alto, California 94303
Received: August 16, 2003
Re: K032460
Trade/Device Name: Profile BBL System 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: July 31, 2003
Dear Mr. Patel:
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. Iisting 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 docs 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 - Mr. Jay M. Patel
This letter will allow you to begin marketing your device as described in your Section 510/kg 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 80) ). please contact the Office of Compliance at (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Mark N. Milken
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 III
Statement of Indications for Use
510(k) Number (if known): K032460
Profile BBL System Device Name:
Indications for Use:
The Profile BBL (and the light and/or laser delivery accessories) is 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 tattoos;
- The treatment of benign pigmented 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, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and ●
- The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair ● reduction.
The integral thermo-electric cooler is indicated for use in cooling the epidernis 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-farget skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/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 21CFR801) | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------------------------ | -------------------------------------------- | ---- | ---------------------- |
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K032960 |
|---|---|
| --------------- | --------- |