(422 days)
No. The document explicitly states "Mentions AI, DNN, or ML - Not Found," and the device description focuses on hardware components and functionalities without any mention of AI models for its operation or indications.
Yes
The device is used for a variety of medical treatments, including the treatment of benign vascular lesions, pigmented lesions, acne scars, and wrinkles, which are all considered therapeutic applications. Additionally, one of the performance standards it complies with is specific to "surgical, cosmetic, therapeutic and diagnostic laser equipment," explicitly listing "therapeutic."
No
This device is intended for aesthetic, cosmetic, and surgical applications involving incision, excision, ablation, vaporization, and coagulation of soft tissues, along with hair and tattoo removal and treatment of various skin lesions. Its stated purpose is therapeutic and cosmetic treatment, not diagnosis. The "Intended Use / Indications for Use" section does not mention any diagnostic capabilities.
No
The device is a complex laser system with multiple hardware components (laser sources, handpieces, power electronics, control electronics, cooling system, optical bench). While it has a graphical user interface and firmware, these software elements control the hardware, which is integral to the device's function. It is not a standalone software application.
No
This device is a laser system intended for aesthetic, cosmetic, and surgical applications, specifically for incision, excision, ablation, vaporization, and coagulation of body soft tissues. It targets conditions such as tattoo removal, pigmented lesions, vascular lesions, hair removal, and skin resurfacing. These applications involve direct interaction with the human body for therapeutic or aesthetic purposes, rather than performing in vitro examinations of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery.
1064 & 532 nm (Q-Switched, nanosecond mode): The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology.
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
- Treatment of benign vascular lesions including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, Cherry angioma, Spider nevi
- Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, Ephalides, solar lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus, Ota Nevus
- Treatment of seborrheic keratosis
- Treatment of post inflammatory hyperpigmentation
- Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- Removal of dark ink (black, blue and brown) tattoos
- Removal of benign pigmented lesions including: nevus of Ota, Café au lait spot, Ephalides, solar lentigo (lentigines), Becker Nevus, Nevus spilus
- Treatment of common nevi
- Removal or lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064 nm (non Q-Switched – free running mode):
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.
- Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
- Coagulation and hemostasis of soft tissue.
- Treatment of wrinkles.
- Treatment of mild to moderate inflammatory acne vulgaris.
532 nm (picosecond mode), also with fractional and microbeam handpieces:
- Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
- Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
- Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
1064 nm (picosecond mode), also with fractional and microbeam handpieces:
- Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
- Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
- Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
- Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
694 nm (Q-Switched), including microbeam handpieces:
Indicated for:
- Tattoo removal: Suggested for blue, sky blue, black, green and violet ink
- Pigmented lesion removal (benign): Cafe au lait spot, Ephalides, solar lentigo lentigines), Becker Nevus, Ota and Ito Nevus, Nevus spilus, Mongolian spot
694 nm (non q-switch – free running mode): Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
IPL 590-1200nm; 625-1200nm; 650-1200nm: Indicated for permanent hair removal. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IPL 550-1200nm; 570-1200nm: Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm: Indicated for inflammatory acne (mild to moderate acne vulgaris).
Integrated Skin Cooler: The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.
Product codes
GEX
Device Description
Discovery Pico family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal. Discovery Pico family includes the following models: Discovery Pico, Discovery Pico Plus, Discovery Pico Derm. Discovery Pico models differ for the installed laser sources and the presence of the Twain connector. The device is equipped with a display with a graphical user interface (GUI) for user-device interaction (e.g. laser parameters settings). Discovery Pico devices can be used in conjunction with Twain IPL and Twain 2940 devices. Laser beam is delivered through an articulated arm with handpiece connected at its end and can be activated with a footswitch. Four types of handpieces are available: Round (diameter): 2 to 12 mm; Square (side): 2, 3, 4, 5, 7 mm; Microbeam/fractional handpieces: 8, 9 mm. 9 mm microbeam handpiece is also called "High Coverage"; Rosso handpiece. The device can be divided into four main sections: Power electronics, Control electronics (microcontroller board with main firmware), Cooling system, and Optical bench. Twain IPL accessory is an intense pulsed light (IPL) optional handpiece intended for hair reduction and treatment of several skin lesions. Twain IPL can be provided cooled or not and with fixed or changeable guides emitting at various wavelength ranges (650-1200 nm, 625-1200 nm, 590-1200 nm, 570-1200 nm, 550-1200 nm, 400-1200 nm). Each guide is available in two different sizes: small (25x13 mm²) and large (48x13 mm²). In PS mode, the user can select three different pulse levels corresponding to pulse durations (VarioPulse technology).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body soft tissues, skin (Fitzpatrick I-VI), face, leg veins.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Health care professionals (dermatologists) in professional healthcare environments.
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)
Non-clinical bench testing was performed according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, IEC 60601-2-22, IEC 60825-1, IEC 60601-2-57, ISO 10993-1, and ISO 17664-1. The results support that the subject device can be used safely and effectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Enlighten III (K160488), Discovery Pico family (K191842)
Reference Device(s)
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.
FDA 510(k) Clearance Letter - Discovery Pico Family
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 6, 2025
Quanta System SpA
Dario Bandiera
Regulatory Affairs Manager
Via Acquedotto 109
Samarate, VA 21017
Italy
Re: K240983
Trade/Device Name: Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX
Dated: May 9, 2025
Received: May 27, 2025
Dear Dario Bandiera:
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 (the 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 available 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.
Page 2
K240983 - Dario Bandiera Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K240983 - Dario Bandiera Page 3
assistance/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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.06.06 17:57:56 -04'00'
Tanisha Hithe
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
Page 4
FORM FDA 3881 (6/20) Page 1 of 3
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K240983
Device Name: Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
Indications for Use (Describe)
General intended use
The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.
Indications for use
1064 & 532 nm (Q-Switched, nanosecond mode)
The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
-
Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos Treatment of benign vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- Cherry angioma
- Spider nevi
-
Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-lait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
-
Treatment of seborrheic keratosis
-
Treatment of post inflammatory hyperpigmentation
-
Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- Removal of dark ink (black, blue and brown) tattoos
- Removal of benign pigmented lesions including:
- nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
Page 5
FORM FDA 3881 (6/20) Page 2 of 3
- Treatment of common nevi
- Removal or lightening of unwanted hair
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064 nm (non Q-Switched – free running mode)
- Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.
- Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
- Coagulation and hemostasis of soft tissue.
- Treatment of wrinkles.
- Treatment of mild to moderate inflammatory acne vulgaris.
532 nm (picosecond mode), also with fractional and microbeam handpieces:
- Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
- Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
- Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
1064 nm (picosecond mode), also with fractional and microbeam handpieces:
- Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
- Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
- Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
- Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
694 nm (Q-Switched), including microbeam handpieces
Indicated for:
- Tattoo removal: Suggested for blue, sky blue, black, green and violet ink
- Pigmented lesion removal (benign):
- Cafe au lait spot
- Ephalides, solar lentigo lentigines)
- Becker Nevus
- Ota and Ito Nevus
- Nevus spilus
- Mongolian spot
694 nm (non q-switch – free running mode)
Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
IPL 590-1200nm; 625-1200nm; 650-1200nm
Indicated for permanent hair removal.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IPL 550-1200nm; 570-1200nm
Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm
Indicated for inflammatory acne (mild to moderate acne vulgaris).
Integrated Skin Cooler
The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such
Page 6
FORM FDA 3881 (6/20) Page 3 of 3
as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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Page 7
510(k) Summary K240983
| Applicant / manufacturer: | Quanta System S.p.A., Via Acquedotto 109, 21017 Samarate (VA), Italy |
|---|---|
| Contact person: | Dario Bandiera |
| RA Manager | |
| Quanta System S.p.A. | |
| Email: dario.bandiera@quantasystem.com | |
| Phone: +39-0331-376797 | |
| Date Prepared: | 24th April 2024 |
| Model name: | Discovery Pico Family including the following models: |
| Discovery Pico, Discovery Pico Plus, Discovery Pico Derm. | |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Predicate device #1 | Enlighten III (K160488) manufactured by Cutera. |
| Predicate device #2 | Discovery Pico family (K191842) manufactured by Quanta System. |
Page 8
1 Abbreviations
- FW = firmware
- FWHM = full width at half maximum
- GUI = graphical user interface
- IPL = intense pulsed light
- OP = Opti-Pulse
- PS = Pico-seconds
- PT = Photo-Thermal
- QS = Q-Switched
- SW = software
2 Device description
General description
Discovery Pico family includes medical laser devices for dermatology and aesthetic medicine. It is used by health care professionals (dermatologists) in professional healthcare environments for the treatment of different skin conditions and hair removal.
Discovery Pico family includes the following models: Discovery Pico, Discovery Pico Plus, Discovery Pico Derm. Discovery Pico models differ for the installed laser sources and the presence of the Twain connector according to Table 1.
Table 1: Discovery Pico family models with installed laser sources.
| Nd: YAG 1064 nm (QS/OP) | Nd: YAG 532 nm (QS/OP) | Nd: YAG 1064 nm (PT) | Ruby 694 nm (QS/PT) | Nd: YAG 1064 nm (PS) | Nd: YAG 532 nm (PS) | Twain connector | |
|---|---|---|---|---|---|---|---|
| Discovery Pico | x | x | x | x | x | x | |
| Discovery Pico Plus | x | x | x | x | x | x | x |
| Discovery Pico Derm | x | x | x |
The device is equipped with a display with a graphical user interface (GUI) for user-device interaction (e.g. laser parameters settings).
Discovery Pico devices can be used in conjunction with Twain IPL and Twain 2940 devices. Twain 2940 is separately FDA cleared (K173002).
Laser beam is delivered through an articulated arm with handpiece connected at its end and can be activated with a footswitch. Four types of handpieces are available:
- Round (diameter): 2 to 12 mm;
- Square (side): 2, 3, 4, 5, 7 mm;
- Microbeam/fractional handpieces: 8, 9 mm. 9 mm microbeam handpiece is also called "High Coverage";
- Rosso handpiece (separately FDA cleared: K211228).
The device can be divided into four main sections:
- Power electronics: they manage power supplied to all device compartments;
- Control electronics: they mainly consist of a microcontroller board where device main firmware (FW) is resident;
- Cooling system: it cools the laser source pumping chamber and, in case of Twain IPL, IPL flashlamp;
- Optical bench.
Page 9
Twain IPL
Twain IPL accessory is an intense pulsed light (IPL) optional handpiece intended for hair reduction and treatment of several skin lesions. Twain IPL can be provided cooled or not and with fixed or changeable guides emitting at the following wavelength ranges:
- 650-1200 nm
- 625-1200 nm
- 590-1200 nm
- 570-1200 nm
- 550-1200 nm
- 400-1200 nm
Moreover, each guide is available in two different sizes: small (25x13 mm²) and large (48x13 mm²).
VarioPulse
In PS mode, the user can select three different pulse levels corresponding to pulse durations as shown in Table 2. Such configuration where pulse duration in PS is settable by the user is optional and is identified as "VarioPulse" technology.
Table 2: Pulse durations corresponding to each pulse level.
| Pulse | Pulse width at 1064 nm | Pulse width at 532 nm |
|---|---|---|
| Short (S) | 450 ps | 370 ps |
| Medium (M) | 600 ps | 500 ps |
| Long (L) | 800 ps | 600 ps |
Page 10
3 Comparison with predicates
In the following table (Table 3) the main specifications of the subject device are summarized and compared to the predicate devices:
Table 3: Main specifications comparison table.
| Specification | Subject device | Predicate device #1 | Predicate device #2 | Equivalence rationale |
|---|---|---|---|---|
| Device Name | Discovery Pico | Enlighten III | Discovery Pico | - |
| K number | - | K160488 | K191842 | - |
| Manufacturer | Quanta System SpA | Cutera | Quanta System | - |
| Product Code | GEX | GEX | GEX | - |
| Laser Sources | Nd:YAG and Ruby | Nd:YAG | Same as the subject device | Same as predicate device #2 |
| Laser Wavelengths (nm) | 1064 QS/OP | |||
| 532 QS/OP | ||||
| 1064 PT | ||||
| 694 (QS/PT) | ||||
| 1064 PS | ||||
| 532 PS | ||||
| IPL (with Twain connector) | ||||
| 2940 (with Twain connector) | 532 (PS, QS), 670, 1064 (PS, QS) | Same as the subject device | Same as predicate device #2 |
Indications for use
General intended use
The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.
Indications for use
1064 & 532 nm (Q-Switched, nanosecond mode)
The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
- Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos Treatment of benign vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
| 532 nm | 670 nm | Same as the subject device | Same as predicate device #2 |
|---|---|---|---|
| • Treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III. | |||
| • Tattoo removal for lighter coloured tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III. | The 670 nm wavelength of the enlighten III laser system is indicated for treatment of benign pigmented lesions on patients with Fitzpatrick skin types I-III. |
1064 nm | | |
Page 11
| Specification | Subject device | Predicate device #1 | Predicate device #2 | Equivalence rationale |
|---|---|---|---|---|
| Device Name | Discovery Pico | Enlighten III | Discovery Pico | - |
- Cherry angioma
- Spider nevi
• Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-lait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
• Removal of dark ink (black, blue and brown) tattoos
• Removal of benign pigmented lesions including:
- nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
• Treatment of common nevi
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064 nm (non Q-Switched – free running mode)
• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.
• Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Treatment of wrinkles.
• Treatment of mild to moderate inflammatory acne vulgaris.
| • Treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI).
• Tattoo removal for dark coloured tattoo inks and for multi-coloured tattoos containing dark coloured tattoo inks on patients with all skin types (Fitzpatrick I-VI). | | |
Page 12
| Specification | Subject device | Predicate device #1 | Predicate device #2 | Equivalence rationale |
|---|---|---|---|---|
| Device Name | Discovery Pico | Enlighten III | Discovery Pico | - |
- Cherry angioma
- Spider nevi
• Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-lait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
• Removal of dark ink (black, blue and brown) tattoos
• Removal of benign pigmented lesions including:
- nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
• Treatment of common nevi
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064 nm (non Q-Switched – free running mode)
• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.
• Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Treatment of wrinkles.
• Treatment of mild to moderate inflammatory acne vulgaris.
| • Treatment of benign pigmented lesions on patients with all skin types (Fitzpatrick I-VI).
• Tattoo removal for dark coloured tattoo inks and for multi-coloured tattoos containing dark coloured tattoo inks on patients with all skin types (Fitzpatrick I-VI). | | |
Page 13
| Specification | Subject device | Predicate device #1 | Predicate device #2 | Equivalence rationale |
|---|---|---|---|---|
| Device Name | Discovery Pico | Enlighten III | Discovery Pico | - |
532 nm (picosecond mode), also with fractional and microbeam handpieces:
• Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
• Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
• Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
1064 nm (picosecond mode), also with fractional and microbeam handpieces:
• Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
• Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
• Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
• Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
694 nm (Q-Switched), including microbeam handpieces
Indicated for:
• Tattoo removal: Suggested for blue, sky blue, black, green and violet ink
• Pigmented lesion removal (benign):
- Cafe au lait spot
- Ephalides, solar lentigo lentigines)
- Becker Nevus
- Ota and Ito Nevus
- Nevus spilus
- Mongolian spot
694 nm (non q-switch – free running mode)
Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
IPL 590-1200nm; 625-1200nm; 650-1200nm
Indicated for permanent hair removal.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IPL 550-1200nm; 570-1200nm
Page 14
| Specification | Subject device | Predicate device #1 | Predicate device #2 | Equivalence rationale |
|---|---|---|---|---|
| Device Name | Discovery Pico | Enlighten III | Discovery Pico | - |
Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm
Indicated for inflammatory acne (mild to moderate acne vulgaris).
Integrated Skin Cooler
The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.
| Pulse widthmax | ▪ @1064 (QS): 6 ns
▪ @1064 (OP): 12 ns
▪ @1064 (PS): 450-800 ps
@1064 (PT): 250 µs
@532 (QS): 6 ns
@532 (OP): 12 ns
▪ @532 (PS): 370-600 ps
▪ @694 (QS): 30 ns
@694 (PT): 2 ms | @1064 (QS): 2 ns
@1064 (PS): 750 ps
@532 (QS): 2 ns
@ 532 (PS): 750 ps
▪ @670 (PS): 660 ps | ▪ @1064 (QS): 6 ns
▪ @1064 (OP): 12 ns
▪ @1064 (PS): 450 ps
@1064 (PT): 250 µs
@532 (QS): 6 ns
@532 (OP): 12 ns
▪ @532 (PS): 400 ps
▪ @694 (QS): 30 ns
@694 (PT): 2 ms | ▪ Higher limit
▪ @1064 (PS): very similar to predicate device #1 (800 vs 750 ps).
▪ @532 (PS): covered by predicate device #1 (600 vs 750 ps).
Lower limit
@532 (PS): very similar to the predicate device #2 (370 vs 400 ps). |
| Spot side (for square handpieces) or diameter (for round handpieces) in mm | Square: 2, 3, 4, 5, 7
Round: 2 to 12
▪ Round (microbeam/fractional): 8, 9 | Round (@1064, 532 nm): 2, 3, 4, 5, 6, 7, 8
Round (@670 nm): 2, 3, 4, 5, 6 | Same as the subject device | Subject device vs predicate device #1 (with homogeneous spots):
Maximum spot area of the subject device is higher than the predicate device #1.
Not clinically significant parameter (higher treated area).
Same as predicate device #2 |
| Repetition ratemax (Hz) | ▪ @1064, 532 (QS/OP/PS/PT): 10
@694 (QS/PT): 3 | 10 | Same as the subject device | Subject device vs predicate device #1 (with homogeneous spots):
@1064 (PS): the same |
Page 15
| Specification | Subject device | Predicate device #1 | Predicate device #2 | Equivalence rationale |
|---|---|---|---|---|
| Device Name | Discovery Pico | Enlighten III | Discovery Pico | - |
@532 (PS): subset of the predicate
Same as predicate device #2
| Energymax (J) | ▪ @1064 (QS): 0.8
▪ @1064 (OP): 1.2
▪ @1064 (PS): 0.8
▪ @1064 (PT): 2
▪ @532 (QS): 0.4
▪ @532 (OP): 0.45
▪ @532 (PS): 0.3
▪ @694 (QS): 1.2
▪ @694 (PT): 2 | @1064: 0.6
@532: 0.3
@670: 0.125 | Same as the subject device | Subject device vs predicate device #1 (with homogeneous spots):
▪ @1064 (PS): similar (0.8 vs 0.6)
▪ @532 (PS): the same
Clinically significant parameter affecting thermal effects is the maximum fluence and not energy.
Same as predicate device #2 |
| Fluencemax (J/cm2) | ▪ @1064 (QS): 20
▪ @1064 (OP): 30
▪ @1064 (PS): 5.6
▪ @1064 (PT): 50
▪ @532 (QS): 10
▪ @532 (OP): 11.25
▪ @532 (PS): 2.8
▪ @694 (QS): 30
▪ @694 (PT): 25 | ▪ @1064 nm: 10
▪ @532 nm: 2.5
▪ @670 nm: 4.0 | Same as the subject device | Subject device vs predicate device #1 (with homogeneous spots):
▪ @1064 (PS): subset (5.6 vs 10)
▪ @532 (PS): similar (2.8 vs 2.5)
Same as predicate device #2 |
With fractional handpiece (8 mm)
| Spot overall dimension (mm) | Round 8 | - | Same as the subject device | Same as predicate device #2 |
| Energymax (J) | @1064 (PS): 0.73
▪ @532 (PS): 0.3 | - | Same as the subject device | Same as predicate device #2 |
| Fluence/dotmax (J/cm2) | @1064 (PS): 18.4
▪ @532 (PS): 8.7 | - | Same as the subject device | Same as predicate device #2 |
| Dot diameter (µm) | @1064 (PS): 200
▪ @532 (PS): 165 | - | Same as the subject device | Same as predicate device #2 |
| Coverage (%) | @1064 (PS): 4
▪ @532 (PS): 3 | - | Same as the subject device | Same as predicate device #2 |
With microbeam handpiece (9 mm)
| Spot overall dimension (mm) | Round 9 | - | Same as the subject device | Same as predicate device #2 |
Page 16
| Specification | Subject device | Predicate device #1 | Predicate device #2 | Equivalence rationale |
|---|---|---|---|---|
| Device Name | Discovery Pico | Enlighten III | Discovery Pico | @532 (PS): subset of the predicate |
Same as predicate device #2 |
| Energymax (J) | @1064 (PS): 0.73
@532 (PS): 0.3
@1064 (QS/OP): 1.2
@532 (QS/OP): 0.45
▪ @694 (QS): 1.2 | @1064: 0.6
@532: 0.3
@670: 0.125 | Same as the subject device | Same as predicate device #2
Subject device vs predicate device #1 (with homogeneous spots):
@1064 (PS): similar (0.8 vs 0.6)
@532 (PS): the same
Clinically significant parameter affecting thermal effects is the maximum fluence and not energy. |
| Fluence/dotmax (J/cm2) | @1064 (PS): 4.2
@532 (PS): 3.1
@1064 (QS/OP): 6
@532 (QS/OP): 3.5
▪ @694 (QS): 3.7 | @1064 nm: 10
@532 nm: 2.5
@670 nm: 4.0 | Same as the subject device | Same as predicate device #2
Subject device vs predicate device #1 (with homogeneous spots):
@1064 (PS): subset (5.6 vs 10)
@532 (PS): similar (2.8 vs 2.5)
Same as predicate device #2 |
| Dot diameter (µm) | @1064 (PS): 550
@532 (PS): 450
@1064 (QS/OP): 550
@532 (QS/OP): 480
▪ @694 (QS): 715 | - | Same as the subject device | Same as predicate device #2 |
| Coverage (%) | @1064 (PS): 27
@532 (PS): 15
@1064 (QS/OP): 26
@532 (QS/OP): 17
▪ @694 (QS): 49.2 | - | Same as the subject device | Same as predicate device #2 |
With microbeam handpiece (8 mm)
| Spot overall dimension (mm) | Round 8 | - | Same as the subject device | Same as predicate device #2 |
| Energymax (J) | @1064 (QS/OP): 0.95
@532 (QS/OP): 0.2
▪ @694 (QS): 1.02 | - | Same as the subject device | Same as predicate device #2 |
| Fluence/dotmax (J/cm2) | @1064 (QS/OP): 38
@532 (QS/OP): 14
▪ @694 (QS): 25 | - | Same as the subject device | Same as predicate device #2 |
| Dot diameter (µm) | @1064 (QS/OP): 210
@532 (QS/OP): 160
▪ @694 (QS): 250 | - | Same as the subject device | Same as predicate device #2 |
| Coverage (%) | @1064 (QS/OP): 5
@532 (QS/OP): 2.5
▪ @694 (QS): 8 | - | Same as the subject device | Same as predicate device #2 |
Twain IPL
| Wavelengths (nm) | 650-1200
625-1200
590-1200
570-1200 | - | Same as the subject device | Same as predicate device #2 |
Page 17
| Specification | Subject device | Predicate device #1 | Predicate device #2 | Equivalence rationale |
|---|---|---|---|---|
| Device Name | Discovery Pico | Enlighten III | Discovery Pico | - |
550-1200
400-1200
| Pulse widthmax | 40 ms | - | Same as the subject device | Same as predicate device #2 |
| Spot size (mm) | 48 x 13
25 x 13 | - | Same as the subject device | Same as predicate device #2 |
| Fluencemax (J/cm2) | 25 | - | Same as the subject device | Same as predicate device #2 |
| Repetition rate (Hz) | 0.5 | - | Same as the subject device | Same as predicate device #2 |
Discussion:
For this pre-market notification, no changes to the indications for use were made, although modifications were made to the Quanta K191842 device resulting in the proposed device. Upon comparison to the predicate devices, the proposed device's laser specifications are considered to be adequate for the safe and effective use of the device for its indications for use listed above.
Page 18
4 Indication for use
General intended use
The Discovery Pico Family is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.
Indications for use
1064 & 532 nm (Q-Switched, nanosecond mode)
The Discovery Pico Family is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
• Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos Treatment of benign vascular lesions including, but not limited to:
- port wine birthmarks
- telangiectasias
- spider angioma
- Cherry angioma
- Spider nevi
• Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-lait birthmarks
- Ephalides, solar lentigines
- senile lentigines
- Becker's nevi
- freckles
- common nevi
- nevus spilus
- Ota Nevus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
• Removal of dark ink (black, blue and brown) tattoos
• Removal of benign pigmented lesions including:
- nevus of Ota
- Café au lait spot
- Ephalides, solar lentigo (lentigines)
- Becker Nevus
- Nevus spilus
• Treatment of common nevi
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064 nm (non Q-Switched – free running mode)
Page 19
• Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin.
• Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins.
• Coagulation and hemostasis of soft tissue.
• Treatment of wrinkles.
• Treatment of mild to moderate inflammatory acne vulgaris.
532 nm (picosecond mode), also with fractional and microbeam handpieces:
• Indicated for the removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
• Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
• Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
• 1064 nm (picosecond mode), also with fractional and microbeam handpieces:
• Indicated for the removal of tattoos for all skin types (Fitzpatrick skin types I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
• Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
• Only with fractional handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV
• Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
694 nm (Q-Switched), including microbeam handpieces
Indicated for:
• Tattoo removal: Suggested for blue, sky blue, black, green and violet ink
• Pigmented lesion removal (benign):
- Cafe au lait spot
- Ephalides, solar lentigo lentigines)
- Becker Nevus
- Ota and Ito Nevus
- Nevus spilus
- Mongolian spot
694 nm (non q-switch – free running mode)
Intended to remove benign dermal and epidermal pigmented lesions, and, to effect hair removal of patients with skin types 1-4 through selective targeting of melanin in hair follicles in dermatology and plastic surgery.
IPL 590-1200nm; 625-1200nm; 650-1200nm
Indicated for permanent hair removal.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IPL 550-1200nm; 570-1200nm
Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
IPL 400-1200nm
Indicated for inflammatory acne (mild to moderate acne vulgaris).
Integrated Skin Cooler
Page 20
The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.
5 Non-clinical tests
The present device was subject to non-clinical bench testing according to the following standards:
Table 4: Applied standards.
| Standard | Discussion | e-star section |
|---|---|---|
| IEC 60601-1: 2005+AMD1: 2012 + AMD2:2020 | ||
| Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | IEC 60601-1 tests have been repeated compared to test reports provided with K191842 due to standards edition update and some minor electrical components changes. | EMC, Wireless, & EMT Documentation |
| IEC 60601-1-2:2014+AMD1:2020 | ||
| Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. | IEC 60601-1-2 tests have been repeated compared to test reports provided with K191842 due to standards edition update and some minor electrical components changes. | EMC, Wireless, & EMT Documentation |
| IEC 60601-1-6:2010/AMD1:2013 | ||
| Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Usability engineering file (not provided with K191842) has been updated due to standards editions update. | - |
| IEC 62366-1:2015 | ||
| Medical devices - Part 1: Application of usability engineering to medical devices | - | |
| IEC 62304:2006/AMD1:2015 | ||
| Medical device software - Software life cycle processes | SW verification and validation activities have been repeated as SW and FW have been updated. | Software/Firmware & Cybersecurity/Interoperability |
| IEC 60601-2-22:2007+AMD1:2012 | ||
| Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment | IEC 60601-2-22 tests have been repeated compared to test reports provided with K191842 due to standard edition update. Additionally, a test report to check pulse duration accuracy (according to IEC 60601-2-22: 2019) has been performed to verify technical change on pulse widths introduced with the present 510K. Pulse duration has been measured considering FWHM. | EMC, Wireless, & EMT Documentation |
| IEC 60825-1: 2014 | Compared to test report provided with K191842, | EMC, Wireless, & EMT Documentation |
Page 21
| Standard | Discussion | e-star section |
|---|---|---|
| Safety of laser products – Part 1: Equipment classification and requirements | IEC60825-1 report has been updated to include Rosso handpiece and some other formal updates. | |
| IEC 60601-2-57: 2011 | ||
| Particular requirements for the basic safety and essential performance of non-laser light source equipment | No changes to Twain IPL affecting IEC60601-2-57 test reports. | - |
| ISO 10993-1: 2009 | ||
| Biological evaluation of medical devices | ||
| Part 1: Evaluation and testing within a risk management process | No changes affecting biocompatibility test reports except from the introduction of disinfection step during reprocessing for which a cytotoxicity test after reprocessing has been performed. | Reprocessing, Sterility, and Shelf-Life or Biocompatibility |
| ISO 17664-1: 2021 | ||
| Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices. | ||
| Part 1: Critical and semi-critical medical devices | Disinfection step has been introduced and thus reprocessing validation has been repeated. | Reprocessing, Sterility, and Shelf-Life |
The results of the non-clinical performance standards testing support that the subject device can be used safely and effectively.
6 Clinical testing
N/A.
7 Conclusions
The proposed device uses the same applicable technology as that used in the predicate devices, and non-clinical performance testing was conducting with the criteria met. The differences in laser output specifications are considered to be adequate and do not raise new types of questions regarding safety and effectiveness for the indications for use. The proposed device is considered to be substantially equivalent to the predicate devices listed above.