(105 days)
No
The device description focuses on mechanical components (motor, needles, depth adjustment) and electrical power, with no mention of AI/ML algorithms, data processing, or learning capabilities.
No.
The device is intended to improve the appearance of scars, which is a cosmetic treatment rather than a therapeutic treatment for a disease or medical condition.
No
The text explicitly states the device is "intended to be used as a treatment to improve the appearance..." and later describes it as a "microneedling device." There is no mention of it being used to diagnose any condition.
No
The device description clearly details a physical, handheld microneedling device with a motor, power source, and disposable needle cartridges, indicating it is a hardware-based medical device, not software-only.
Based on the provided text, the SkinStylus SteriLock® MicroSystem is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used as a treatment to improve the appearance of scars on the abdomen and facial acne scars. This is a therapeutic or cosmetic application, not a diagnostic one.
- Device Description: The description details a microneedling device that creates channels and microinjuries in the skin. This is a physical intervention on the body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- No mention of diagnostic testing: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SkinStylus SteriLock® MicroSystem does not fit this description.
N/A
Intended Use / Indications for Use
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.
Product codes (comma separated list FDA assigned to the subject device)
QAI
Device Description
The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles.
The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side.
The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm.
The removable nosecone interface provides the SkinStylus® the unique ability to have an interface between the motor and the cartridge to ensure there is a secondary control preventing any fluid from entering the motor body. The removable nosecone is autoclave sterilized after every use.
The SkinStylus® disposable cartridge is designed in a 36-needle array with all needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge.
The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11(Method A)(C/S Analyzer) was also completed and is attached.
Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy under report #GM2015012518. Certifications on file with sponsor and available for review.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen, facial
Indicated Patient Age Range
22 years or older
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
A new clinical trial was not conducted to support the additional indications for use and overall safety of the device.
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)
Non-Clinical Test Reports: The following tests were performed on the SkinStylus SteriLock® MicroSystem device and the test results show that the subject device is substantially equivalent to the predicate Device.
- Biocompatibility: Cytotoxity - ISO 10993-5:2009; Sensitization - ISO 10993-10:2010; Irritation - Intracutaneous Injection Test GLP - ISO 10993-10:2010; Systemic Toxicity – Systemic Injection GLP - ISO 10993-11:2017; Pyrogenicity ISO 10993; Metallurgical Analysis – GLP - ASTM E1019-11(Method A)(C/S Analyzer)
- Sterilization Validation: Sterilization of Health Care Products - Moist heat ISO 17665-1:2006; Sterilization of Medical Devices ISO 11737-1: 2006; Sterilization of Medical Devices ISO 11737-2: 2009; Sterility and Bacteriostasis/Fungistasis Tests ISO 11737-2: 2009 and USP 71
- Reprocessing Validation: ISO 11737-1: 2018 (AAMI TIR-30; 2011; AAMI TIR-12:2004)
- Fluid Ingress Validation: SkinStylus Sterilock Microsystem Leak Testing Report from MicroChem Laboratories
- Shelf-life Testing: Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM F88/F88M-15; Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration ASTM F1929-15; Standard Test Method for Microbial Ranking of Porous Packaging Materials ASTM F1608-16
- Electrical Safety and Electromagnetic Compatibility: IEC 60601-1-2 and 60601-1
- Depth Penetration Validation: Internal Method - Depth Penetration Report
- Needle Reciprocal Rate Validation: Internal Method - Needle Reciprocal Rate Report
- Clinician Usability Study: Internal Method - Usability Report
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.
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
§ 878.4430 Microneedling device for aesthetic use.
(a)
Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
July 28, 2023
Esthetic Medical Inc. % Marc Sanchez Regulatory Attorney Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty) 1717 Pennsylvania Ave NW Suite 1025 Washington, District of Columbia 20006
Re: K231073
Trade/Device Name: SkinStylus SteriLock® MicroSystem, Model Number MP1209SL Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: QAI Dated: May 12, 2023 Received: May 12, 2023
Dear Marc Sanchez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mark
Digitally signed by
Mark Trumbore -S
Trumbore -S Date: 2023.07.28
13:54:57 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SkinStylus SteriLock® MicroSystem
Indications for Use (Describe)
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------- |
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3
5. 510(K) Summary
The following information is provided as required by 21 CFR 807.92 for the SkinStylus SteriLock® MicroSystem 510(k) premarket notification.
| Sponsor: | Esthetic Medical Inc.
Attention: Lawrence Groop
7950 E. Acoma Drive Suite 208
Scottsdale, AZ 85260
Establishment Registration: 3011338460 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | GUANGZHOU CARAIN BEAUTY EQUIPMENT
103 & 601, No. 3 of Xin Liu Mu Road,
Zhong Cun Street
Guangzhou Guangdong, CHINA 511495
Establishment Registration: 3011568699 |
| Contact: | Marc C. Sanchez, Esq.
Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty)
1717 Pennsylvania Ave NW Suite 1025 Washington D.C. 20006
Ph: 202.765.4491
E-mail: msanchez@fdaatty.com) |
| Date of Submission: | July 28, 2023 |
| Proprietary Name: | SkinStylus SteriLock® MicroSystem |
| Common Name: | Powered Microneedle Device |
Regulation Number: 21 CFR 882.4810
Regulatory Class: Class II
Product Code: QAI
Predicate Device(s): Collagen P.I.N. (Percutaneous Induction Microneedling) System (K222199).
Device Description:
The SkinStylus SteriLock® MicroSystem is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles.
4
Traditional 510k Submission SkinStylus SteriLock® MicroSystem
The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side.
The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm.
The removable nosecone interface provides the SkinStylus® the unique ability to have an interface between the motor and the cartridge to ensure there is a secondary control preventing any fluid from entering the motor body. The removable nosecone is autoclave sterilized after every use.
The SkinStylus® disposable cartridge is designed in a 36-needle array with all needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge.
The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11(Method A)(C/S Analyzer) was also completed and is attached.
Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy under report #GM2015012518. Certifications on file with sponsor and available for review.
Intended Use:
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 or older. The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, and III in patients aged 22 years and older.
5
Summary of Clinical Test Reports
A new clinical trial was not conducted to support the additional indications for use and overall safety of the device.
Non-Clinical Test Reports
The following tests were performed on the SkinStylus SteriLock® MicroSystem device and the test results show that the subject device is substantially equivalent to the predicate Device.
| Test Completed | Standard |
|---|---|
| BiocompatibilityA | Cytotoxity - ISO 10993-5:2009 |
| Sensitization -ISO 10993-10:2010 | |
| Irritation - Intracutaneous Injection Test GLP - ISO | |
| 10993-10:2010 | |
| Systemic Toxicity – Systemic Injection GLP - ISO | |
| 10993-11:2017 | |
| Pyrogenicity ISO 10993 | |
| Metallurgical Analysis – GLP - ASTM E1019- | |
| 11(Method A)(C/S Analyzer) | |
| Sterilization ValidationB | Sterilization of Health Care Products - Moist heat |
| ISO 17665-1:2006 | |
| Sterilization of Medical Devices ISO 11737-1: 2006 | |
| Sterilization of Medical Devices ISO 11737-2: 2009 | |
| Sterility and Bacteriostasis/Fungistasis Tests ISO | |
| 11737-2: 2009 and USP 71 | |
| Reprocessing ValidationB | ISO 11737-1: 2018 (AAMI TIR-30; 2011; AAMI |
| TIR-12:2004) | |
| Fluid Ingress ValidationB | SkinStylus Sterilock Microsystem Leak |
| Testing Report from MicroChem Laboratories | |
| Shelf-life TestingB | Standard Test Method for Seal Strength of Flexible |
| Barrier Materials ASTM F88/F88M-15 | |
| Standard Test Method for Detecting Seal Leaks in | |
| Porous Medical Packaging by Dye Penetration | |
| ASTM F1929-15 |
Table 1 Summary of Non-Clinical Performance Testing
6
| | Standard Test Method for Microbial Ranking of
Porous Packaging Materials ASTM F1608-16 |
|---------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Electrical Safety and Electromagnetic
CompatibilityC | IEC 60601-1-2 and 60601-1 |
| Depth Penetration ValidationD | Internal Method - Depth Penetration Report |
| Needle Reciprocal Rate Validation | Internal Method - Needle Reciprocal Rate Report |
| Clinician Usability Study | Internal Method - Usability Report |
| A Mitigation measure for adverse tissue reaction. | |
B Mitigation measure for cross-contamination and infection.
C Mitigation measure for electrical shock or electromagnetic interference with other devices.
D Mitigation measure for Damage to underlying tissue including nerves and blood vessels, scarring, and hyper/hypopigmentation due to exceeding safe penetration depth or mechanical failure. **
**NOTE: The proposed device contains NO software
Summary of Substantial Equivalence
The SkinStylus SteriLock® MicroSystem and the predicate are for similar uses and rely on the same mode of action. Both devices include disposable needle cartridges with design features to mitigate the likelihood of cross-contamination between patients and to prevent needle depth greater than 2.5mm. Both devices also include a redundant safety feature to ensure no fluid enters the motor or housing.
7
| Table 2 |
|---|
| Technological Characteristics |
| Technological Characteristics | ||||
|---|---|---|---|---|
| Device | ||||
| Name/Model | SkinStylus SteriLock® | |||
| MicroSystem | ||||
| Subject Device | Collagen P.I.N. | |||
| (Percutaneous Induction | ||||
| Microneedling) System | ||||
| Predicate Device | SkinStylus SteriLock® | |||
| MicroSystem | ||||
| Reference Device | Comments | |||
| 510(k) | ||||
| Number | K231073 | K222199 | K200044 | N/A |
| Indication for | ||||
| Use | The SkinStylus SteriLock® MicroSystem | |||
| is intended to be used as a treatment to | ||||
| improve the appearance of surgical or | ||||
| traumatic hypertrophic scars on the | ||||
| abdomen in adults aged 22 years or older. | ||||
| The SkinStylus SteriLock® MicroSystem | ||||
| is a microneedling device and accessories | ||||
| intended to be used as a treatment to | ||||
| improve the appearance of facial acne | ||||
| scars in Fitzpatrick skin types I, II, and III | ||||
| in patients aged 22 years and older. | Intended to be used as a | |||
| treatment to improve the | ||||
| appearance of facial acne | ||||
| scars in Fitzpatrick skin | ||||
| types I-III in patients | ||||
| aged 22 years and older | Intended to be used as | |||
| a treatment to improve | ||||
| the appearance of | ||||
| hypertrophic | ||||
| abdominal scarring | Subject device | |||
| same as predicate | ||||
| device | ||||
| Mode of | ||||
| Action | Microneedling (using | |||
| one or more needles to | ||||
| mechanically puncture | ||||
| and injure skin tissue for | ||||
| aesthetic use) | Microneedling (using one | |||
| or more needles to | ||||
| mechanically puncture and | ||||
| injure skin tissue for | ||||
| aesthetic use) | Microneedling (using | |||
| one or more needles to | ||||
| mechanically puncture | ||||
| and injure skin tissue for | ||||
| aesthetic use) | Same | |||
| Power Source | ||||
| 1 | 5 Volt DC/1 amp | |||
| rechargeable | ||||
| lithium-ion battery | 5 Volt DC/1 amp | |||
| rechargeable lithium-ion | ||||
| battery | 5 Volt DC/1 amp | |||
| rechargeable lithium-ion | ||||
| battery | Same | |||
| Power Source | ||||
| 2 | AC Adapter 5VC | |||
| +/-, 1A minimum | AC Adapter 5VC +/-, | |||
| 1A minimum | AC Adapter 5VC | |||
| +/-, 1A minimum | Same | |||
| Range of | ||||
| Needle Length | 0.0-2.5mm | 0.0mm-3.0mm | 0.0-2.5mm | - Similar to |
| predicate device | ||||
| -Needle penetration | ||||
| of subject device is | ||||
| .5mm less than | ||||
| predicate device | ||||
| which has been | ||||
| cleared to 3.0mm | ||||
| Maximum | ||||
| Penetration | 2.5mm | 3.0mm | 2.5mm | - Similar to |
| predicate device | ||||
| -Needle penetration | ||||
| of subject device is | ||||
| .5mm less than | ||||
| predicate device | ||||
| which has been | ||||
| cleared to 3.0mm | ||||
| Needle | ||||
| Geometry | 36 solid needles | 36 solid needles | 36 solid needles | Same |
| Speed | 6200- 8840 RPM | 7000 RPM-9000 RPM | 6200- 8840 RPM | Negligible |
| difference in RPM | ||||
| Does not impact | ||||
| the safety or | ||||
| efficacy of the | ||||
| subject device | ||||
| Cross | ||||
| Contamination | ||||
| Safety Feature | Cartridge design and | |||
| intermediate disinfected | ||||
| handpiece and nosecone | ||||
| with optional reprocessed | ||||
| (autoclave sterilized) | ||||
| nosecone; | Cartridge design and | |||
| intermediate disinfected | ||||
| handpiece and nosecone | ||||
| with optional reprocessed | ||||
| (autoclave sterilized) | ||||
| nosecone; | Cartridge design and | |||
| intermediate disinfected | ||||
| handpiece and nosecone | ||||
| with optional | ||||
| reprocessed (autoclave | ||||
| sterilized) nosecone; | Same | |||
| Sterility and | ||||
| Cleaning | Disposable cartridge | |||
| Gamma Ray Sterilized | ||||
| prior to packaging | Disposable cartridge | |||
| Ethylene Oxide Sterilized | ||||
| prior to packaging | Disposable cartridge | |||
| Gamma Ray Sterilized | ||||
| prior to packaging | Both devices use | |||
| approved methods | ||||
| for cartridge | ||||
| sterilization. | ||||
| Does not impact | ||||
| the safety or | ||||
| efficacy of the | ||||
| subject device |
8
Traditional 510k Submission
SkinStylus SteriLock® MicroSystem
9
Traditional 510k Submission SkinStylus SteriLock® MicroSystem
Conclusion:
Therefore, taking into consideration Table 2 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the SkinStylus SteriLock® MicroSystem raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device. Further, the predicate device has been cleared for 3.0mm needle penetration, whereas the subject device (and already cleared reference device) has a maximum needle penetration of only 2.5mm.