(87 days)
Not Found
No
The description focuses on the laser technology, handpieces, and user interface. There is no mention of AI, ML, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration in medical devices.
Yes
The device is intended for various medical procedures such as tattoo removal, treatment of acne scars, wrinkles, and vascular lesions, which are considered therapeutic applications.
No
The device description indicates it is a laser system used for aesthetic, cosmetic, and surgical applications, performing actions like incision, ablation, and vaporization of soft tissues. Its intended uses involve treatment procedures (e.g., tattoo removal, skin resurfacing, wrinkle treatment) rather than diagnosing conditions.
No
The device description clearly details a physical laser system with hardware components like a resonator, articulated arm, handpieces, and a footswitch. While it has a software-controlled interface, it is fundamentally a hardware device that uses software for control.
Based on the provided information, the HOLLYWOOD SPECTRA System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the system is for "aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatological and general surgical procedures for coagulation and hemostasis." It also lists various skin treatments and tattoo removal. These are all procedures performed on the patient's body, not on samples taken from the patient's body.
- Device Description: The description details a laser system that delivers energy to human tissue to cause physical changes (fragmentation of chromophores, temperature increase). This is a therapeutic or surgical action, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The HOLLYWOOD SPECTRA System is a medical device used for treatment and surgical procedures directly on the patient.
N/A
Intended Use / Indications for Use
The HOLLYWOOD SPECTRA System is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatological and general surgical procedures for coagulation and hemostasis.
1064nm in nanosecond mode, including microbeam handpieces:
- Tattoo removal: dark ink (black, blue, and brown)
- Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of melasma
1064nm in Spectra (long-pulse) mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532mm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585 nm and 650 mm with optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of Lentigines
- Treatment of Café-au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyperpigmentation
- Treatment of Becker's Nevi, Freckles, and Nevi spilus
Product codes
GEX
Device Description
The HOLLYWOOD SPECTRA Laser System contains a Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates Q-switched and/or pulsed laser sources at the nominal wavelength of 1064 nm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (655 nm) are delivered by articulated arm to a fixed (collimated), or focusing variable (zoom) spot handpiece, or a dual focused dots microbeam handpiece, or a 585nm/650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or 650 nm wavelengths, correspondingly.
When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromophores such as melanin and tattoo particles. This increases localized temperature of the chromophores. The instantaneous temperature-increase causes fragmentation of the chromophores to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.
The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size. The HOLLYWOOD SPECTRA laser system is controlled via a touchscreen guided user interface in the front of the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data provided include biocompatibility testing, sterilization and shelf-life information, electrical safety and electromagnetic compatibility (EMC) testing, software verification and validation testing, and performance bench testing.
Biocompatibility Testing
The tip of handpiece is considered tissue-contacting component for a duration of less than 24 hours and its chemical formulation is Aluminum (Max. 96%, CAS No. 7429-90-S). The contact type of the HOLLYWOOD SPECTRA Laser System is as follows: surface device, intact skin, limited duration. The biocompatibility evaluation was conducted in accordance with ISO 10993-1, ISO 10993-5, and ISO 10993-10.
Tests:
- Cytotoxicity
- Dermal Sensitization
- Intracutaneous Irritation
Sterilization and Shelf-Life
The HOLLYWOOD SPECTRA Laser System is not provided sterile and does not need to be sterilized. It is reusable and does not have a restricted shelf-life. The expected service life is about 5 years.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the HOLLYWOOD SPECTRA Laser System. The system complies with IEC 60601-1:2012, IEC 60601-1-2 Edition 4: 2014, IEC 60601-2-22: 2012-10, and IEC 60825-1 Ed. 3.0 (2014).
Software Verification and Validation Testing
Software verification and validation testing was 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." The software for this device was considered as a "moderate" level of concern.
Performance Bench Testing
Test was performed to ensure that the HOLLYWOOD SPECTRA Laser System performs as intended and documentation was provided. Testing included laser pulse width, laser pulse repetition rate, laser pulse energy, laser beam spectrum and bandwidth, laser beam spot size, and flash lamp lifetime.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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 and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 4, 2022
Lutronic Corporation Haewon Park Regulatory Affairs Specialist Lutronic Center, 219, Sowon-Ro Deogyang-gu, Goyang-Si, Geonggi-do 410220 Korea, South
Re: K213569
Trade/Device Name: HOLLYWOOD SPECTRA Laser System 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 29, 2021 Received: November 9, 2021
Dear Haewon Park:
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.
Purva Pandya 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) K213569
Device Name HOLLYWOOD SPECTRA Laser System
Indications for Use (Describe)
The HOLLYWOOD SPECTRA System is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatological and general surgical procedures for coagulation and hemostasis.
1064nm in nanosecond mode, including microbeam handpieces:
- Tattoo removal: dark ink (black, blue, and brown)
- Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of melasma
1064nm in Spectra (long-pulse) mode:
- Treatment of wrinkles
- Treatment of mild to moderate inflammatory acne vulgaris
532mm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585 nm and 650 mm with optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
- Treatment of Lentigines
- Treatment of Café-au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyperpigmentation
- Treatment of Becker's Nevi, Freckles, and Nevi spilus
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.
3
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4
510(k) SUMMARY (K213569)
Lutronic Corporation HOLLYWOOD SPECTRA Laser System
I. SUBMITTER
Lutronic Corporation Lutronic Center 219, Sowon-Ro Deogyang-Gu, Goyang-Si, Gyeonggi-do, 10534 Republic of Korea
Contact Person
Haewon Park, PhD 19 Fortune Dr. Billerica, MA 01821 Phone: 1-978-447-4763
Date Revised: January 31st, 2022
II. DEVICE
| Trade Name: | HOLLYWOOD SPECTRA Laser System |
|---|---|
| Common or Usual Name: | Surgical Laser |
| Classification Name: | GEX – Powered Laser Surgical Instrument For Use in General and |
| Plastic Surgery and Dermatology | |
| 21 C.F.R. 878.4810, Class II |
III. PREDICATE DEVICES
| 1. Primary Predicate Device | |
|---|---|
| Trade Name: | SPECTRA Laser System |
| Common or Usual Name: | Surgical Laser |
| Classification Name: | GEX – Powered Laser Surgical Instrument for use in General and |
| Plastic Surgery and Dermatology | |
| 21 C.F.R. 878.4810, Class II | |
| Premarket Notification: | Lutronic Corporation K113588 (2/2/2012) |
| 2. Secondary Predicate Device | |
| Trade Name: | Chrome |
| Common or Usual Name: | Surgical Laser |
| Classification Name: | GEX - Powered Laser Surgical Instrument for use in General and |
| Plastic Surgery and Dermatology | |
| 21 C.F.R. 878.4810, Class II | |
| Premarket Notification: | Quanta System SPA K202503 (11/18/2020) |
5
| 3. Tertiary Predicate Device | |
|---|---|
| Trade Name: | Fotona QX Nd:YAG/KTP Laser System Family |
| Common or Usual Name: | Nd:YAG/KTP Dermatology and Surgical Laser |
| Classification Name: | GEX – Powered Laser Surgical Instrument for use in General and |
| Plastic Surgery and Dermatology | |
| 21 C.F.R. 878.4810, Class II | |
| Premarket Notification: | Fotona d.o.o K083889 (4/23/2009) |
IV. DEVICE DESCRIPTION
The HOLLYWOOD SPECTRA Laser System contains a Nd: YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates Q-switched and/or pulsed laser sources at the nominal wavelength of 1064 nm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (655 nm) are delivered by articulated arm to a fixed (collimated), or focusing variable (zoom) spot handpiece, or a dual focused dots microbeam handpiece, or a 585nm/650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or 650 nm wavelengths, correspondingly.
When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromophores such as melanin and tattoo particles. This increases localized temperature of the chromophores. The instantaneous temperature-increase causes fragmentation of the chromophores to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.
The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size. The HOLLYWOOD SPECTRA laser system is controlled via a touchscreen guided user interface in the front of the device.
V. INDICATIONS FOR USE
The HOLLYWOOD SPECTRA Laser System is intended for use in aesthetic, cosmetic and surgical applications requiring incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
1064nm in nanosecond mode, including microbeam handpieces:
- Tattoo removal: dark ink (black, blue, and brown) -
6
- -Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation -
- -Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkles -
- Treatment of melasma -
1064nm in Spectra (long-pulse) mode:
- Treatment of wrinkles -
- Treatment of mild to moderate inflammatory acne vulgaris -
532nm in nanosecond mode, including microbeam handpieces (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) -
- Removal of Epidermal Pigmented Lesions -
- Removal of Minor Vascular Lesions including but not limited to telangiectasias -
- Skin resurfacing procedures for the treatment of acne scars and wrinkles -
- Treatment of Lentigines -
- Treatment of Café-au-Lait -
- Treatment of Seborrheic Keratoses -
- Treatment of Post Inflammatory Hyperpigmentation -
- Treatment of Becker's Nevi, Freckles, and Nevi spilus -
7
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
Lutronic Corporation believes that the HOLLYWOOD SPECTRA Laser System described in this notification and for use under the conditions of the proposed labeling is substantially equivalent to three legally marketed predicate devices that are Class II medical device. As shown in the Technical Characteristics Comparison (Table 1), the 1064 nm and 532 nm functions of the HOLLYWOOD SPECTRA Laser System are substantially equivalent to the 1064 nm and 532 nm functions of the Lutronic Corporation SPECTRA Laser System, Quanta Chrome, and Fotona QX Nd:YAG/KTP Laser System Family. As shown in Table 2, the microbeam handpiece's technological and performance characteristics of the HOLLYWOOD SPECTRA Laser System are substantially equivalent to those of the Quanta Chrome's standard microbeam handpiece.
Utilizing FDA's Guidance for Industry and FDA Staff "Format for traditional and Abbreviated 510(k)s", the proposed device, the HOLLYWOOD SPECTRA Laser System is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The HOLLYWOOD SPECTRA Laser System is as safe, as effective, and performs as well as the predicate devices.
8
Table 1. Technical Characteristics Comparison
| | This Submission
HOLLYWOOD
SPECTRA | Predicate 1
SPECTRA | Predicate 2
Chrome | Predicate 3
Fotona QX |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 510(k) | K213569 | K113588 | K202503 | K083889 |
| Applicant | Lutronic | Lutronic | Quanta | Fotona d.o.o |
| Product Code
Classification
Regulation Num | GEX
Class II
21 CFR 878.4810 | GEX
Class II
21 CFR 878.4810 | GEX
Class II
21 CFR 878.4810 | GEX
Class II
21 CFR 878.4810 |
| Laser Source
Wavelength | Nd:YAG
1064nm, 532nm | Nd:YAG
1064nm, 532nm | Nd:YAG
1064nm, 532nm | Nd:YAG
1064nm, 532nm |
| Modes | QS Mode
Q-PTP, Q-3, Q-4 Mode
Spectra Mode (Long-pulse
Mode)
532 Mode | QS Mode
Spectra Mode (Long-
pulse Mode)
532 Mode | QS Mode
IPL
Pulsed Mode | QS Mode
Long-Pulse Mode |
| Pulse Duration | 1064 nm
5-10 ns (QS, Q-PTP mode)
10-20 ns (Q-3, Q-4 mode)
0.3 ms (Long-pulse) | 1064 nm
5-10 ns (QS)
0.3 ms (Long-pulse) | 1064 nm
6 -12 ns (QS)
0.3-50 ms (Pulsed mode) | 1064 nm
5-20 ns (QS)
0.25 ms (Long pulse) |
| | 532 nm
5-10 ns (Q-switched) | 532 nm
5-20 ns (Q-switched) | 532 nm
6 -12 ns (Q-switched)
IPL
Up to 40 ms (IPL) | 532 nm
5-20 ns (Q-switched) |
| Max Energy | 1064 nm
Up to 1200 mJ (Q-switched)
Up to 1500 mJ (Spectra)
Up to 1400 mJ (Q-PTP, Q-3,
Q-4) | 1064 nm
Up to 1200 mJ (Q-
switched)
Up to 1500 mJ (Spectra) | 1064nm
Up to 1600 mJ (Q-
switched)
Up to 15000 mJ (long
pulsed) | 1064 nm
Up to 1600 mJ (Q-
switched)
Up to 5000 mJ (long
pulsed) |
| | 532 nm
Up to 400 mJ (Q-switched) | 532 nm
Up to 600 mJ (Q-
switched) | 532nm
Up to 800 mJ (Q-
switched) | 532 nm
Up to 600 mJ (Q-
switched) |
| | | | IPL
NA | |
| Max. Fluence | 1064 nm
Up to 12 J/cm² | 1064 nm
Up to 12 J/cm² | 1064 nm
Up to 48 J/cm² (Q-
switched)
Up to 300 J/cm² (pulsed
mode) | 1064 nm
Up to 12.7 J/cm² |
| | 532 nm
Up to 6.3 J/cm² | 532 nm
Up to 6.3 J/cm² | 532 nm
Up to 15 J/cm² (Q-
switched) | |
| Spot Size | 1064 nm | 1064 nm | 1064 nm | 1064, 532 nm |
| | Zoom handpiece
1 to 7 mm (Q-Switch, Spectra)
2 to 7 mm (Q-PTP, Q-3, Q-4)
8mm-Zoom-Collimated
3, 4, 5, 6, 7, 8 mm | Zoom handpiece
1 to 7 mm (Q-Switch, Spectra)
8mm-Zoom-Collimated
3, 4, 5, 6, 7, 8 mm | 2 to 8 mm diameter
2x2, 3x3, 4x4, 5x5, 7x7 mm²
532 nm
3 to 10.5 mm diameter | 2 to 8 mm diameter |
| | 532 nm
Zoom handpiece
0.8 to 6.0 mm diameter
8mm-Zoom-Collimated
2.6, 3.4, 4.3, 5.2, 6.0, 6.9 mm | 532 nm
Zoom handpiece
0.8 to 6.0 mm diameter
8mm-Zoom-Collimated
2.6, 3.4, 4.3, 5.2, 6.0, 6.9 mm | | |
| Repetition Rate | 1064, 532 nm
Up to 10 Hz
585nm S1, 1, 2, 5 Hz
650nm S1, 1, 2 Hz | 1064, 532 nm
Up to 10 Hz | 1064, 532 nm
Up to 20 Hz | 1064, 532 nm
Up to 10 Hz |
| Delivery | Articulated arm | Articulated arm | Articulated arm | Articulated arm |
9
Table 2. Technological Characteristics Comparison for the Microbeam Handpiece
| | This Submission
HOLLYWOOD
SPECTRA | Predicate 1
SPECTRA | Predicate 2
Chrome | Predicate 3
Fotona QX |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K213569 | K113588 | K202503 | K083889 |
| Applicant | Lutronic | Lutronic | Quanta | Fotona d.o.o |
| Microbeam
Handpiece | Present | Absent | Present | Absent |
| Microbeam
Handpiece
Fluence per dot | 1064 nm
1.09~40.63 J/cm²
532 nm
0.1616.40 J/cm² | NA | 1064nm44.4 J/cm² (Standard)
0.03
0.2~16.5 J/cm² (High Coverage)
532 nm
0.314.9 J/cm² (Standard)5.95 J/cm² (High
0.05
Coverage) | NA |
| Microbeam
Handpiece
Spot Size | 1064 nm
8mm
532 nm
6.9mm | NA | 1064, 532 nm
8 mm (Standard)
9 mm (High Coverage) | NA |
| Microbeam
Handpiece
Peak Power per
dot** | 0.28 GW (1064 nm)
0.08 GW (532 nm) | NA | 0.3 GW (1064 nm)
0.083 GW (532 nm) | NA |
| | This Submission
HOLLYWOOD SPECTRA
K213569 | Predicate 1
SPECTRA
K113588 | Predicate 2
Chrome
K202503 | Predicate 3
Fotona QX
K083889 |
| 510(k) | | | | |
| Applicant | Lutronic | Lutronic | Quanta | Fotona d.o.o |
| Indication For
Use | The Hollywood Spectra System is
intended for use in aesthetic, cosmetic
and surgical applications requiring
incision, excision, ablation,
vaporization of soft tissues for general
dermatology, dermatologic and general
surgical procedures for coagulation
and hemostasis. | The SPECTRA Laser System is
indicated for the incision, excision,
ablation, vaporization of soft tissues
for general dermatology, dermatologic
and general surgical procedures for
coagulation and hemostasis. | Quanta Chrome (K202503) is cleared for
the 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: | 1064 nm wavelength in Q-
switched mode:
- Removal of dark ink (black,
blue, and brown) tattoos - Treatment of nevus of Ota
- Treatment of common nevi
- Removal or lightening of
unwanted hair - Skin resurfacing procedures
for the treatment of acne scars
and wrinkles |
| | 1064nm in nanosecond mode,
including microbeam handpieces:
-Tattoo removal: dark ink (black, blue,
and brown)
-Removal of Nevus of Ota
-Removal or lightening of unwanted
hair with or without adjuvant
preparation
-Treatment of Common Nevi
-Skin resurfacing procedures for the
treatment of acne scars and wrinkles
-Treatment of melasma | 532nm Wavelength (nominal
delivered energy of 585 nm and 650
nm with optional dye handpieces): - Tattoo removal: light ink (red, tan,
purple, orange, sky blue, green) - Removal of Epidermal Pigmented
Lesions - Removal of Minor Vascular Lesions
including but not limited to
telangiectasias - Treatment of lentigines
- Treatment of Café-au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory
Hyperpigmentation - Treatment of Becker's Nevi,
Freckles, and Nevi Spilus | 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. | |
| | 1064nm in Spectra (long-pulse)
mode:
-Treatment of wrinkles
-Treatment of mild to moderate
inflammatory acne vulgaris | 1064 nm Wavelength: - Tattoo removal: dark ink (black, blue
and brown) - Removal of Nevus of Ota
- Removal or lightening of unwanted
hair with or without adjuvant
preparation - Treatment of Common Nevi
- Skin resurfacing procedures for the
treatment of acne scars and wrinkles - Treatment of melasma | 1064 nm (Q-Switched, nanosecond
mode), including microbeam handpieces:
Removal of dark ink (black, blue and
brown) tattoos
Removal of benign pigmented lesions
including | 1064 nm wavelength in non-
Q-switched 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 pigmented and
vascular lesions, such as, but
not limited to, - port wine stains,
hemangioma, warts,
telangiectasia, 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 |
| | 532nm in nanosecond mode,
including microbeam handpieces
(nominal delivered energy of 585 nm
and 650 nm with optional dye
handpieces): - Tattoo removal: light ink (red, tan,
purple, orange, sky blue, green) - Removal of Epidermal Pigmented
Lesions | | | |
** Mathematically derived values
10
Table3. Indications for Use Statement Comparison
11
| - Removal of Minor Vascular Lesions
including but not limited to
telangiectasias
- Skin resurfacing procedures for the
treatment of acne scars and wrinkles - Treatment of Lentigines
- Treatment of Café-au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory
Hyperpigmentation - Treatment of Becker's Nevi,
Freckles, and Nevi spilus | - 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 (pulsed) Dermatology/Plastic
Surgery:
Intended for the coagulation and hemostasis
of benign vascular lesions such as, but not
limited to, port wine stains, hemangiomas,
warts, telangectasia, rosacea, venus lake,
leg veins, spider veins and poikiloderma of
civatte; and treatment of benign cutaneous
lesions such as warts, scars, striae and
psoriasis. The laser is also intended for the
treatment of benign pigmented lesions such
as, but not limited to, lentigos (age spots),
solar lentigos (sun spots), cafe au lait
macules, seborrheic keratoses, nevi,
chloasma, verrucae, skin tags, keratosis and
plaques. The laser is also indicated for the
treatment of wrinkles such as, but not
limited to, periocular and perioral wrinkles.
The laser is also indicated for the treatment
of facial wrinkles. Additionally, the laser is
indicated for the treatment of
pseudofolliculitis barbae (PFB) and for
stable long-term, or permanent hair
reduction. Permanent hair reduction is
defined as 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. It is indicated for the
reduction of red pigmentation in
hypertrophic and keloid scars where
vascularity is an integral part of the scar.
The laser is also indicated for benign
pigmented lesions to reduce lesion size, for
patients with benign lesions that would
potentiallybenefit from aggressive
treatment, and for patients with benign
lesions that have not responded to other
laser treatments. It is indicated for use on all
skin types (Fitzpatrick I-VI) including
tanned skin, and the removal and permanent | 532 un wavelength in Q-
switched mode (nominal
delivered energy of 585 nm
and 650 nm with the
optional 585 nm and 650 nm
dye converter handpieces):
- Removal of light ink (red,
sky blue, green, tan, purple,
and orange) tattoos - Treatment of vascular
lesions including, but not
limited to: - port wine birthmarks
- telangiectasias
- spider angioma
- cherry angioma
- spider nevi | | reduction of unwanted hair in Fitzpatrick I-
VI, including suntanned skin types.
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. | |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The tip of handpiece is considered tissue-contacting component for a duration of less than 24 hours and its chemical formulation is Aluminum (Max. 96%, CAS No. 7429-90-S). The contact type of the HOLLYWOOD SPECTRA Laser System is as follows: surface device, intact skin, limited duration.
The biocompatibility evaluation for the HOLLYWOOD SPECTRA Laser System was conducted in accordance with the FDA's Guidance for Industry and FDA Staff "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," ISO 10993-5, "Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity," and ISO 10993-10, "Biological Evaluation of Medical Devices -Part 10: Tests for irritation and skin sensitization' as recognized by FDA. The handpiece tip testing included the following tests:
- . Cytotoxicity
- . Dermal Sensitization
- Intracutaneous Irritation
Sterilization and Shelf-Life
The HOLLYWOOD SPECTRA Laser System is not provided sterile and does not need to be sterilized. The handpiece and the body are cleaned with a soft cloth moistened with isopropyl alcohol or ethanol of 90% strength or higher. The HOLLYWOOD SPECTRA Laser System is reusable and does not have a restricted shelf-life. The expected service life is about 5 years.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the HOLLYWOOD SPECTRA Laser System, consisting of the system main body, articulated arm, handpieces, and footswitch. The system complies with the following standards for safety and EMC.
-
IEC 60601-1:2012, ed 3.1, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
-
IEC 60601-1-2 Edition 4: 2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
-
IEC 60601-2-22: 2012-10 ed 3.1, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment
14
- IEC 60825-1 Ed. 3.0 (2014) Safety of laser products - Part 1: Equipment classification and requirements
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." The software for this device was considered as a "moderate" level of concern since a failure of the software could result in minor injury to a patient or to a user of the device.
Performance Bench Testing
Test was performed to ensure that the HOLL YWOOD SPECTRA Laser System performs as intended and documentation was provided. Testing included laser pulse width, laser pulse repetition rate, laser pulse energy, laser beam spectrum and bandwidth, laser beam spot size, and flash lamp lifetime.
VIII. CONCLUSIONS
The HOLLYWOOD SPECTRA Laser System has the same intended use, similar indications for use, and the same fundamental scientific technology as its predicates. The technology and performance specifications of the subject device are equivalent to its identified predicate devices and therefore do not present any new concerns of safety and effectiveness. Therefore, the HOLLYWOOD SPECTRA Laser System is as safe, as effective, and performs as well as the legally marketed predicate devices.