Discovery Pico, Discovery Pico Plus
Device Facts
| Record ID | K172376 |
|---|---|
| Device Name | Discovery Pico, Discovery Pico Plus |
| Applicant | Quanta System Spa |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Oct 19, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 as follows.
Device Story
Laser system utilizing Q-switched, picosecond, and free-running pulsed laser sources (532nm, 1064nm, 694nm) and optional IPL handpieces (400-1200nm range). Device delivers light energy to soft tissues for aesthetic/surgical procedures. Operated by clinicians in dermatology, plastic, or oral surgery settings. Controlled via front-panel touchscreen; emission triggered by footswitch. Optical delivery via articulated arm or IPL handpiece. Optional integrated contact/air cooling system reduces pain and side effects. Output effects include photothermolysis, ablation, and coagulation, facilitating tissue modification or lesion removal. Benefits include precise tissue treatment, tattoo clearance, and hair reduction.
Clinical Evidence
Bench testing only. Compliance with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards. Thermal-histology performance data provided for fractional handpieces. Biocompatibility established via predicate devices.
Technological Characteristics
Laser sources: Q-switched, picosecond, free-running pulsed (532nm, 1064nm, 694nm). IPL wavelengths: 400-1200nm. Delivery: Articulated arm or IPL handpiece. Cooling: Integrated contact/air. Control: Touchscreen, footswitch. Standards: IEC 60601-1, 60601-2-22, 60825-1, 60601-1-2.
Indications for Use
Indicated for tattoo removal, benign vascular/pigmented lesion treatment, hair removal/reduction, acne scar/wrinkle treatment, and soft tissue coagulation/hemostasis. Patient population includes Fitzpatrick skin types I-VI depending on wavelength and mode. Contraindications not explicitly listed, but specific skin type limitations apply to certain modes (e.g., 532nm picosecond for types I-III).
Regulatory Classification
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.
Predicate Devices
- Discovery Pico Family (K171945)
Reference Devices
- PicoWay Laser System (K170597)
Submission Summary (Full Text)
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October 19, 2017
Quanta System S.p.A. Francesco Dell'antonio V.P. Regulatory Affairs & Quality Assurance Via Acquedotto, 109 Samarate, VA 20826, IT
Re: K172376
Trade/Device Name: Discovery Pico Family 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: October 17, 2017 Received: August 7, 2017
Dear Francesco Dell'antonio:
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. 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.
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
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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 contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
# Jennifer R. Stevenson -S3
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K172376
Device Name Discovery Pico Family
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 surgerv 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, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
532 nm (Q-Switched, nanosecond mode)
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 angiomaa
- Cherry angioma
- Spider nevi
- Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-Iait 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)
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
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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 handpiece
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-V
1064 nm (picosecond mode), also with fractional handpiece
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)
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.
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#### 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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## 5. 510(K) SUMMARY
| Applicant /<br>Manufacturer<br>Name and Address: | Quanta System SPA<br>Via Acquedotto, 109<br>Samarate (VA)<br>Italy 21017 |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Francesco Dell'Antonio<br>Vice President Regulatory Affairs and QA<br>Quanta System SPA<br>Email: francesco.dellantonio@quantasystem.com<br>Phone: +39-0331-376797<br>Fax: +39-0331-367815 |
| Date Prepared: | 16th October , 2017 |
| Device Name: | Discovery Pico Family |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology. |
| Regulation Number: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Primary predicate device | Discovery Pico Family (K171945), Quanta System SpA |
| Reference predicate device | PicoWay Laser System (K170597), SYNERON CANDELA<br>CORPORATION |
The modified device Discovery Pico Family is derived from the legally marketed (unmodified) device Discovery Pico Family (K171945).
## Performance Standards:
There are no mandatory performance standards for this device.
## Description of the device (unchanged from K171945):
The Discovery Pico Family is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at one or more of the following wavelengths: 532 nm, 1064 nm, 694 nm (Ruby laser) The Discovery Pico Family systems, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.
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The Discovery Pico Family systems, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.
The optical delivery system is an articulated arm with fixed handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.
All the models belonging to the Discovery Pico Family have the same components and the same control software. The only difference between different models is the optical bench that depends on the sources installed.
The Discovery Pico Family is controlled via a touch screen display housed in the front of the device.
Emission is triggered by means of a footswitch.
## Intended use
The intended use and the indications for use of the modified device and the unmodified device are exactly the same, as follows.
## 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, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:
## 532 nm (Q-Switched, nanosecond mode)
Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos Treatment of benign vascular lesions including, but not limited to:
- י port wine birthmarks
- י telangiectasias
- spider angiomaa
- -Cherry angioma
- -Spider nevi
Treatment of benign pigmented lesions including, but not limited to:
- cafe-au-lait birthmarks
- Ephalides, solar lentigines l
- senile lentigines
- -Becker's nevi
- freckles
- common nevi
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- י 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)
Removal of dark ink (black, blue and brown) tattoos Removal of benign pigmented lesions including;
- nevus of Ota ı
- Café au lait spot ।
- । Ephalides, solar lentigo (lentigines)
- -Becker Nevus
- i 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 handpiece
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-V
# 1064 nm (picosecond mode), also with fractional handpiece
Indicated for the removal of tattoos for all 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-V Only with fractional handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V
# 694 nm (Q-Switched)
Indicated for: Tattoo removal: Suggested for blue, sky blue, black, green and violet ink Pigmented lesion removal (benign):
- i Cafe au lait spot
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- -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.
## Performance data:
Discovery Pico family devices comply with the following recognized consensus standards:
- IEC 60601-2-22 Third Edition 2007-05, Medical Electrical Equipment Part 2-22: Particular . Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
- . IEC 60825-1 Edition 3.0: 2014, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements
- . IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
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- . IEC 60601-1-2 Edition 3: 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- . Thermal-histology performance data for fractional handpieces
## Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
## Biocompatibility:
The biocompatibility of the Discovery Pico Family is established based on the predicate devices.
## Comparison with predicate device:
The subject device and primary predicate have comparable general intended use and technological characteristics. Expanded specific indications for use for the fractional handpieces are supported by comparable technological specification within the subject device and the reference predicate.
Any minor differences do not present any new types of safety or effectiveness questions since the Discovery Pico Family parameters are similar to or within the range of the predicates.
## Summary
Testing of the Discovery Pico Family demonstrated that the device performs as intended. The Discovery Pico Family is substantially equivalent to the predicate devices.
