(82 days)
Not Found
No
The description focuses on computer-controlled power supply, flash-lamp, and filters to generate light pulses, without mentioning any AI/ML capabilities for image analysis, treatment planning, or other functions. The "Mentions AI, DNN, or ML" section is also marked as "Not Found".
Yes
The device is intended for medical use in the treatment of various dermatologic conditions, indicating a therapeutic purpose.
No
The device is intended for treatment of various dermatologic conditions and offers cooling functionalities. There is no mention of it being used to diagnose conditions.
No
The device description explicitly states it is an "intense pulsed light system" and describes hardware components like a power supply, xenon flash-lamp, band-pass filter, and cooling systems. While it mentions "computer software regulates" the power outflow, the core functionality relies on physical light generation and delivery, not solely software processing.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The StrataPulse and StrataPulse TS IPL Systems are described as intense pulsed light systems used for treating various dermatologic conditions. They apply light energy directly to the body.
- Lack of Sample Analysis: There is no mention of this device analyzing any biological samples taken from a patient. Its function is therapeutic, not diagnostic based on in vitro analysis.
The device is a therapeutic device that uses light energy for treatment, not an IVD that analyzes samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The StrataPulse and StrataPulse TS IPL Systems are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:
- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a . treatment regimen.
- . Treatment of:
- Moderate inflammatory acne vulgaris o
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, 0 ephelides (freckles).
- Cutaneous lesions including scars 0
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, o truncal and leg telangiectasias, erythema of rosacea, leg veins and venous malformations.
- . Integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during and after light treatment in general aesthetic dermatologic and plastic surgery . procedures to:
- Reduce pain during light treatment (via partial anesthesia from cooling). o
- Reduce discomfort during and/or associated with light treatment o
- Minimize thermal injury, including thermal necrosis, to non-targeted skin and skin o structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hype- and/or hypo pigmentation.
- 0 Allow the use of higher light or laser fluences for light treatments (such as for hair reduction and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light treatment (such as for hair reduction and the 0 treatment of vascular or pigmented lesions)
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
The StrataPulse IPL system is an intense pulsed light system. This device uses computer controlled power supply, xenon flash-lamp and band-pass filter to generate light pulses of prescribed duration, intensity and spectral distribution. The device is also equipped with cooling systems to maintain both the treatment head and the internal structure of the device at appropriate and safe temperatures. The light pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the device. More specifically, the computer software regulates in a prescribed fashion the outflow of power from the power supply to the flash-lamp such that a flash of intense pulsed light is generated.
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
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)
No performance data is required for this Class II device nor requested by the Food and drug Administration (Office of Device Evaluation). A database search has been conducted to evaluate any adverse effects of the device currently marketed.
No data submitted for section 807.92 6[(b)(1)(2)(3c)]. See attached documentation of adverse effects for predicate devices listed on Page 27 of this document.
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
pg 1 of 3
5. 510(k) Summary
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.
1. General Information
Submitter:
Advanced Medical Photonics 1384 Via Colonna Terrace Davis, CA 95618 USA
JUN 1 7 2009
Contact Person:
Common Name:
Classification Name:
Scott Porter Director of Regulatory Affairs Advanced Medical Photonics 1384 Via Colonna Terrace Davis, CA 95618 Tel: (530) 219-4089 MedEngine(@gmail.com
Summary Preparation Date:
March 9, 2007
- Device Name and Classification
Proprietary Name:
StrataPulse IPL System (Model STRATAPULSE TS and Model STRATAPULSE)
IPL System Laser surgical instrument for use in General and Plastic Surgery and in Dermatology. Product Code: ONF Regulation Number: 21 CFR 878.4810
3. Legally-marketed Equivalent Devices
Accelawave System: K082484
The StrataPulse IPL System (Model STRATAPULSE TS and Model STRATAPULSE) is substantially equivalent to other legally marketed flash lamp intense pulsed light devices (please reference, Section 12, Substantial Equivalence Discussion, Table 3, of this document).
1
pg 2 of 3
4. Device Description
The StrataPulse IPL system is an intense pulsed light system. This device uses computer controlled power supply, xenon flash-lamp and band-pass filter to generate light pulses of prescribed duration, intensity and spectral distribution. The device is also equipped with cooling systems to maintain both the treatment head and the internal structure of the device at appropriate and safe temperatures. The light pulses or emission spectra provide therapeutic indications relevant to specific wavelengths emitted from the device. More specifically, the computer software regulates in a prescribed fashion the outflow of power from the power supply to the flash-lamp such that a flash of intense pulsed light is generated.
5. Indications for Use
Indications For Use (For Fitzpatrick Skin Types See Indications and Filters vs. Skin Types Chart Below):
The StrataPulse and StrataPulse TS IPL Systems are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:
- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a . treatment regimen.
- . Treatment of:
- Moderate inflammatory acne vulgaris o
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, 0 ephelides (freckles).
- Cutaneous lesions including scars 0
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, o truncal and leg telangiectasias, erythema of rosacea, leg veins and venous malformations.
- . Integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during and after light treatment in general aesthetic dermatologic and plastic surgery . procedures to:
- Reduce pain during light treatment (via partial anesthesia from cooling). o
- Reduce discomfort during and/or associated with light treatment o
- Minimize thermal injury, including thermal necrosis, to non-targeted skin and skin o structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hype- and/or hypo pigmentation.
- 0 Allow the use of higher light or laser fluences for light treatments (such as for hair reduction and the treatment of vascular or pigmented lesions)
- Reduce potential side effects of light treatment (such as for hair reduction and the 0 treatment of vascular or pigmented lesions)
6. Performance Data
2
K090837 pg 3 A3
No performance data is required for this Class II device nor requested by the Food and drug Administration (Office of Device Evaluation). A database search has been conducted to evaluate any adverse effects of the device currently marketed.
No data submitted for section 807.92 6[(b)(1)(2)(3c)]. See attached documentation of adverse effects for predicate devices listed on Page 27 of this document.
Conclusion:
A comparison of the indications and the technical characteristics of the StrataPulse IPL system and the legally marketed device including the Accelawave System lead to the conclusion that the pertinent characteristics of the StrataPulse IPL system are substantially similar to the legally marketed devices. In this capacity the StrataPulse IPL system is substantially equivalent to device approved for marketing by the FDA and does not result in different performance or raise new questions of safety or efficacy.
| Similarities/Differences | Accelawave System |
|---|---|
| Output Spectrum Characteristics | Similar |
| Output Pulse Characteristics | Similar, Programmable |
| Treatment Parameters | Similar, Programmable |
| Skin Cooling/Epidermal Cooling | Similar, Cold Contact Cooling |
Side Effects:
In extreme cases, effects from treatment can include excessively red patches in the shape of the applicator head and blistering. If this occurs the tissue should be cooled and cared for as would normally be the case with burns to the skin, i.e. do not burst any blister formation, keep clean and cover until healed.
If blister form, they are usually intra-epidermal in nature and heal without scarring. Inappropriate management of blisters during the healing stage will increase the chance of scarring.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized eagle or bird-like figure.
Public Health Service
JUN 17 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Advanced Medical Photonics % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo. Minnesota 55313
Re: K090837
Trade/Device Name: StrataPulse IPL System (Model StrataPulse TS and StrataPulse) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Instrument, Surgical, Powered Regulatory Class: II Product Code: ONF Dated: May 28, 2009 Received: June 2, 2009
Dear Mr Job:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
4
Page 2-Mr. Mark Job
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/industry/support/index.html.
Sincerely yours,
for Abn. R.A.
J.N. Miller
Mark N. Melk erson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
4. Indications for Use
510(k) Number:
Device Name: StrataPulse IPL System (Model StrataPulse TS and StrataPulse)
Indications For Use (For Fitzpatrick Skin Types See Indications and Filters vs. Skin Types Chart Below):
The StrataPulse and StrataPulse. TS IPL Systems are identical with regard to indications for use including recommended filters to be used with Fitzpatrick skin type. Both models are intended for medical use in the treatment of the following dermatologic conditions:
- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a . treatment regimen.
- Treatment of:
- Moderate inflammatory acne vulgaris o.
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, o ephelides (freckles).
- Cutaneous lesions including scars o
Page 1 of
-
Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, 0 truncal and leg telangiectasias, erythema of rosacea, leg veins and venous malformations.
Integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during and after light treatment in general aesthetic dermatologic and plastic surgery procedures to: -
Reduce pain during light treatment (via partial anesthesia from cooling). o
-
Reduce discomfort during and/or associated with light treatment o
-
Minimize thermal injury, including thermal necrosis, to non-targeted skin and skin o ' structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hype- and/or hypo pigmentation.
-
Allow the use of higher light or laser fluences for light treatments (such as for hair D reduction and the treatment of vascular or pigmented lesions)
-
Reduce potential side effects of light treatment (such as for hair reduction and the o treatment of vascular or pigmented lesions)
Neil RPO. Lr mkm
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090837
2 relating to indications for use.
6
K090837 pg 2 of 2
Indication and Filters vs. Skin Types for StrataPulse and StrataPulse TS
| CONDITIONS | I | II | III | IV | V | VI |
|---|---|---|---|---|---|---|
| Hair (course) | 640-1200 | 640-1200 | 640-1200 | 640-1200 | 690-1200 | N/A |
| Hair (fine) | 640-1200 | 640-1200 | 640-1200 | 640-1200 | 690-1200 | N/A |
| Acne Vulgaris | 420-1200 | 420-1200 | 420-1200 | 420-1200 | N/A | N/A |
| Pigmented | ||||||
| Epidermal Lesions | ||||||
| a) Dyschromia | 510-1200 | 510-1200 | 510-1200 | 560-1200 | N/A | N/A |
| b) Hyperpigmentation | 510-1200 | 510-1200 | 510-1200 | 560-1200 | N/A | N/A |
| c) Melasma | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | N/A |
| d) Ephelides | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | N/A |
| Cutaneous Lesions | ||||||
| Scars | 560-1200 | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A |
| Cutaneous Vascular | ||||||
| Lesions | ||||||
| a) Port wine stain (child) | 510-1200 | 510-1200 | 510-1200 | N/A | N/A | N/A |
| b) Port wine stain (adult) | 510-1200 | 510-1200 | 510-1200 | N/A | N/A | N/A |
| c) Hemangiomas | 560-1200 | 560-1200 | 560-1200 | N/A | N/A | N/A |
| d) Telangiectasias | 510-1200 | 510-1200 | 510-1200 | N/A | N/A | N/A |
| e) Rosacea | 560-1200 | 560-1200 | 560-1200 | 560-1200 | N/A | N/A |
| i) Venous Malformations | 560-1200 | 560-1200 | N/A | N/A | N/A | N/A |
| Leg Veins | ||||||
| a) Small | 510-1200 | 510-1200 | 510-1200 | N/A | N/A | N/A |
| b) Medium | 560-1200 | 560-1200 | 560-1200 | N/A | N/A | N/A |
| c) Large | 560-1200 | 560-1200 | 560-1200 | N/A | N/A | N/A |
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Milke Ogden Larkin
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090837
relating to indications for use. Page 2 of 2