(86 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on basic microprocessor control and laser operation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "treatment" of various conditions, and one of the performance studies conducted was based on "IEC 60601-2-22 Medical electrical equipment part 2-22: particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment," which includes therapeutic devices.
No
The device is indicated for treatment purposes (e.g., coagulation, hemostasis, hair reduction, wrinkle treatment), not for identifying or characterizing diseases or conditions. The "Indications for Use" section lists therapeutic applications, not diagnostic ones.
No
The device description explicitly states it is composed of a main body and a handpiece which is an irradiation device, indicating it is a hardware-based laser system, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a laser system used for various dermatological and cosmetic procedures on the human body (coagulation, hemostasis, hair reduction, treatment of lesions and wrinkles). IVDs are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device description details a laser system with a handpiece for irradiation, protective goggles, and a control panel. This aligns with a therapeutic or cosmetic device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the ORION device, as described, is a medical device used for therapeutic and cosmetic purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
532nm
The ORION is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions[angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
755 nm
The ORION is indicated for stable long-term, or permanent hair reduction which 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. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm
The ORION is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus, spider veins and poikiloderma of civate; 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, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which 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 through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The subject device is composed of the main body and a handpiece which is an irradiation device and as an accessory part, protective goggles for protection of the worker.
It is controlled by a micro processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board.
Meanwhile, the control board connected to the touch screen is connected to the lamp of the handpiece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will laser.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- IEC 60601-1 Medical electrical equipment - part 1: general requirements for basic safety and essential performance
- IEC 60601-1-6 Medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
- IEC 62366-1 Medical devices part 1: application of usability engineering to medical devices.
- IEC 60601-2-22 Medical electrical equipment part 2-22: particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. (Radiology)
- IEC 60601-1-2 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. (General II (ES/EMC))
- IEC 60825-1 Edition 2.0 2007-03, safety of laser products - part 1: equipment classification, and requirements [including: technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]. (Radiology)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure with outstretched arms, resembling an eagle or bird in flight. The figure is composed of three overlapping profiles, creating a sense of depth and movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2016
Yerim Engineering Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620
Re: K161503
Trade/Device Name: Orion 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 23, 2016 Received: June 1, 2016
Dear Priscilla Chung:
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
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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 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 yours,
Christopher J. Ronk -S
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
2
Indications for Use
510(k) Number (if known) K161503
Device Name
ORION
Indications for Use (Describe)
532nm
The ORION is indicated for coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions[angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions (nevi, lentigines, chloasma, cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
755 nm
The ORION is indicated for stable long-term, or permanent hair reduction which 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. It is used for all skin types (Fitzpatrick I- VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm
The ORION is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus, spider veins and poikiloderma of civate; 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, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which 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 through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
| 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 (K161503)
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Aug 19, 2016
1. Applicant / Submitter:
YERIM ENGINEERING Co., Ltd. Ga-307, Techno-zone ,117, Hwanggeum-ro, Yangchon-eup, Gimpo-si, Gyeonggi-do 415-843 Republic of Korea Tel : +82-31-991-9841 Fax : +82-31-991-9845
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Phone: 714-202-5789, Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | ORION |
|---|---|
| Common Name: | Medical Laser System |
| Classification Name: | Instrument, Surgical, Powered, Laser |
| Classification: | Class II, 21 CFR 878.4810 |
| Classification Product Code: | GEX |
4. Predicate Device:
■ Primary Predicate Device: Family of Altus Medical Modified Cool Glide Aesthetic Lasers by Altus Medical, Inc. (K014040) ■ Reference Predicate Device:
Cynosure Apogee Elite Laser by CYNOSURE, INC. (K034030)
CLARITY LPC Laser System by Lutronic Corporation (K130199)
5
5. Device Description:
The subject device is composed of the main body and a handpiece which is an irradiation device and as an accessory part, protective goggles for protection of the worker.
It is controlled by a micro processor interfaced to a LCD touch screen control panel. The computer controls start and stop of the treatment. When the key switch of the system is turned clockwise, the main power will be inputted, which will be conveyed to the hand piece through the control board.
Meanwhile, the control board connected to the touch screen is connected to the lamp of the handpiece and controls the same, and controls the whole system through the data connected to the touch screen control panel. When the switch of the hand piece is pressed, the lamp will laser.
6. Indications for Use:
532nm
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology including, but not limited to, the following general categories: vascular lesions[angiomas, hemangiomas (port wine), telangiectasia (facial or extremities telangiectasias venous anomalies, leg veins)); benign pigmented lesions (nevi, lentigines, chloasma,cafk-au-lait, tattoos (red and green ink); verrucae; skin tags; keratoses; plaques; cutaneouslesion treatment (hemostasis, color lightening, flattening, reduction of lesion size).
755 nm
The ORION is indicated for stable long-term, or permanent hair reduction which 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. It is used for all skin types (Fitzpatrick I- VI) including tanned skin.
It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles.
1064 nm
The ORION is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, 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, keratoses, tattoos (sigmificant reduction in the intensity of black and/or blue/black tattoos) and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent hair reduction which 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 through selective targeting of melanin in hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
6
Performance Data(Non-Clinical): 7.
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- . IEC 60601-1 Medical electrical equipment - part 1: general requirements for basic safety and essential performance
- . IEC 60601-1-6 Medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
- IEC 62366-1 Medical devices part 1: application of usability engineering to medical devices. .
- IEC 60601-2-22 Medical electrical equipment part 2-22: particular requirements for basic . safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. (Radiology)
- . IEC 60601-1-2 Medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests. (General II (ES/EMC))
- . IEC 60825-1 Edition 2.0 2007-03, safety of laser products - part 1: equipment classification, and requirements [including: technical corrigendum 1 (2008), interpretation sheet 1 (2007), interpretation sheet 2 (2007)]. (Radiology)
8. Substantial Equivalence
The ORION is substantially equivalent to the Family of Altus Medical Modified Cool Glide Aesthetic Lasers by Altus Medical, Inc. (K014040), Cynosure Apogee Elite Laser by CYNOSURE, INC. (K034030) and CLARITY LPC Laser System by Lutronic Corporation (K130199).
The following comparison table is presented to demonstrate substantial equivalence.
| | | Subject Device | Primary Predicate
Device | Reference
Predicate Device | Reference
Predicate Device | |
|-----------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | | | |
| Device name | | ORION | Family of Altus
Medical Modified
CoolGlide
Aesthetic
Lasers (Primary
Predicate) | Cynosure Apogee
Elite Laser
(Reference
Predicate) | CLARITY LPC
Laser System
(Reference
Predicate) | |
| Manufacturer | | YERIM
ENGINEERING
Co., Ltd. | Altus Medical, Inc. | CYNOSURE, INC. | Lutronic
Corporation | |
| 510(k) number | | K161503 | K014040 | K034030 | K130199 | |
| Technology | | Long Pulse
Nd:YAG | Long Pulse
Nd:YAG | Long Pulse
Nd:YAG | Long Pulse
Nd:YAG | |
| Power (CW Laser) | | AC220 - 240
V/16A | 110 - 120
VAC/20A
220 - 240
VAC/20A | 200/220 VAC/30A | 4.0kVA(AC2202300ms | 0.3 - 300 ms | Adjustable
30V) | |
| Energy | 1064nm | 100J | 100J | 100J | 100J | |
| (pulse and | 755nm | 50J | - | 50J | 55J | |
| super pulse) | 532nm | 10J | 10J | n/a | n/a | |
| If pulsed, how is this done | | Long pulse | Long pulse | Long pulse | Long pulse | |
| Frequency of
pulse | 1064 nm | 1Hz | 2Hz | 5Hz | Up to 10Hz | |
| | 755nm | 3Hz | - | 3Hz | Up to 10Hz | |
| | 532nm | 2Hz | 2Hz | | n/a | |
| Pulse train
duration | 1064 nm | 0.1
0.4- 300 msec | 0.35 ms - 300 ms | |
| | 755nm | 0.1300ms | | Adjustable300ms | 0.3 - 300 ms | | | |
0.5 – 300 msec | 0.35 ms - 300 ms | |
| | 532nm | 0.1
| Spot size at target | | 220mm | 10mm | 324mm | 2, 3, 5, 8, 10, 12,
15, 18, 20 mm | |
| Wavelength | | 1064 nm,
755nm,
532nm | 1064 nm,
532nm | 1064 nm,
755nm | 1064 nm,
755nm | |
| Aiming beam | | 650nm | 650 nm | 650nm | 650nm | |
| Energy source | | Nd:YAG,
Alexandrite, KTP | Nd-YAG, KTP | Nd:YAG,
Alexandrite | Nd:YAG,
Alexandrite | |
| Cooling method | | Cold air | Sapphire cooling | Cold air | Cold air | |
| Intended use | 532nm | The ORION is
indicated for
coagulation and
hemostasis of
vascular and
cutaneous lesions
in
dermatologyincludi
ng, but not limited
to, the following
general categories:
vascular
lesions[angiomas,
hemangiomas (port
wine),
telangiectasia
(facial or
extremities
telangiectasias,ven
ous anomalies, leg
veins)]; benign
pigmented lesions
(nevi, lentigines,
chloasma,cafk-au-
lait, tattoos (red
and green ink);
verrucae; skin tags;
keratoses; plaques;
cutaneouslesion
treatment | For coagulation
and hemostasis of
vascular and
cutaneous lesions
in
dermatologyincludi
ng, but not limited
to, the following
general categories:
vascular
lesions[angiomas,
hemangiomas (port
wine),
telangiectasia
(facial or
extremities
telangiectasias,ven
ous anomalies, leg
veins)]; benign
pigmented lesions
(nevi, lentigines,
chloasma,cafk-au-
lait, tattoos (red
and green ink);
verrucae; skin tags;
keratoses; plaques;
cutaneouslesion
treatment
(hemostasis, color
lightening, | | | |
| | | lightening,
blanching,
flattening,
reduction of lesion
size). | flattening,
reduction of lesion
size). | | | The CLARITY
LPC Laser System
is indicated for
temporary hair
reduction. Stable
long-term or
permanent
reduction through
selective targeting
of melanin in hair
follicles.
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.
On all skin types
(Fitzpatrick 1-VI)
including tanned
skin. Treatment of
benign pigmented
lesions. Treatment
of wrinkles. The
photocoagulation
of dermatological
vascular lesions
(such as port-wine
stains,
hemangiomas,
telangiectasias). |
| | 755 nm | The ORION is
indicated for stable
long-term, or
permanent hair
reduction.
Permanent hair
reduction is
defined as long-
term stable
reduction in the
number of hair
regrowth after a
treatment regime. It
is used for all skin
types (Fitzpatrick
I- VI) including
tanned skin.
It is also indicated
for the treatment of
vascular lesions,
benign pigmented
lesions, and
wrinkles. | - | The Cynosure
Apogee Elite
Dermatological
Laser is indicated
for stable long-
term, or permanent
hair reduction.
Permanent hair
reduction is
defined as long-
term stable
reduction in the
number of hair
regrowth after a
treatment regime. It
is used for all skin
types (Fitzpatrick
I- VI) including
tanned skin.
It is also indicated
for the treatment of
vascular lesions,
benign pigmented
lesions, and
wrinkles. | | |
| | 1064 nm | The ORION is
intended for the
coagulation and
hemostasis of
benign vascular
lesions such as, but
not limited to, port
wine stains,
hemangiomas,
warts,
telangiectasia, | Dermatology:
The Altus Medical
Aesthetic
CoolGlide laser
systems are
intended for
thecoagulation and
hemostasis of
benign vascular
lesions such as, but
not limited toport
wine stains, | The Cynosure
Apogee Elite
Dermatological
laser is intended for
the coagulation and
hemostasis of
benign vascular
lesions such as, but
not limited to, port
wine stains,
hemangiomas,
warts, | | The CLARITY
LPC Laser System
is indicated for the
removal of
unwanted hair, for
stable long term or
permanent hair
reduction and for
treatment of PFB.
Permanent hair
reduction is
defined as the long- |
7
8
9
| | | | | | gastroenterology,
general surgery,
head
andneck/otorhinola
ryngology (ENT),
neurosurgery,
oculoplastics,
orthopedics,
plastic surgery,
pulmonary/thoracic
surgery,
gynecology (e.g.
menorrhagia)
andurology. | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| lake, leg veins,
spider veins
andpoikiloderma of
civatte; and
treatment of benign
cutaneous lesions
such as warts,
scars, striaeand
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,
keratoses, tattoos
(significantreductio
n in the intensity of
black and/or
blue/black tattoos)
and plaques.
The laser is also
indicated for the
treatment of
wrinkles such as,
but not limited to,
periocularand
perioral wrinkles.
Additionally, the
laser is indicated
for the removal of
unwanted hair, for
the stable long
term, or permanent,
hair reduction
through selective
targeting of
melanin in hair
follicles, and for
thetreatment of
pseudofolliculitis
barbae (PFB). | hemangiomas,
warts,
telangiectasia,
rosacea, Venus
lake, legveins and
spider veins. The
lasers are also
intended for the
treatment of
benignpigmented
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,
keratoses,
tattoos(significant
reduction in the
intensity of black
and/orblue/black
tattoos) and
plaques.
Additionally, the
lasers are indicated
forpigmented
lesions to reduce
lesion size, for
patients with
lesions that
wouldpotentially
benefit from
aggressive
treatment, and for
patients with
lesions thathave
not responded to
other laser
treatments.
The CoolGlide
lasers are also
indicated for the
removal of
unwanted hair, for
thestable long term,
or permanent, hair
reduction through
selective targeting | telangiectasia,
rosacea, venus
lake, leg veins,
spider veins
andpoikiloderma of
civatte; and
treatment of benign
cutaneous lesions
such as warts,
scars, striaeand
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,
keratoses, tattoos
(significantreductio
n in the intensity of
black and/or
blue/black tattoos)
and plaques.
The laser is also
indicated for the
treatment of
wrinkles such as,
but not limited to,
periocularand
perioral wrinkles.
Additionally, the
laser is indicated
for the removal of
unwanted hair, for
the stable long
term,or permanent,
hair reduction
through selective
targeting of
melanin in hair
follicles, and for
thetreatment of
pseudofolliculitis
barbae (PFB). | term, stable
reduction in the
number of hairs
regrowing when
measured at 6, 9,
and 12 months
after the
completion of a
treatment regime.
The lasers are
indicated on 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,
hemangiomna,
warts,
telangiectasia,
rosacea, venus
lake, leg veins and
spider veins.
Coagulation and
hemostasis of soft
tissue. 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,
keratoses, tattoos
(significant.
reduction in the
intensity of black
and/or blue-black
tattoos) and
plaques. The laser
is indicated for
pigmented lesions
to reduce lesion
size, for patients
with lesions that
selective tar | | | |
| | | | | | | |
| | ofmelanin in hair
follicles, and for
the treatment for
pseudofolliculitis
barbae (PFB).
The lasers are also
indicated for the
reduction of red
pigmentation in
hypertrophic
and keloid scars
where vascularity
is an integral part
of the scar.
The CoolGlide
lasers are indicated
for use on all skin
types (Fitzpatrick
I-VI),including
tanned skin.
The intended use of
the integral cooling
system in the Altus
handpiece is
toprovide cooling
of the skin prior to
laser treatment, for
the reduction of
painduring laser
treatment, to allow
for the use of
higher fluences for
laser
treatmentssuch as
hair removal and
vascular lesions,
and to reduce the
potential side
effectsof laser
treatments.
Surgical
Applications:
The lasers are
indicated for the
incision/excision
and cutting,
ablation,coagulation/hemostatis of soft
tissue in the
performance of
surgical
applications
inendosopy/laprosc | would potentially
benefit from
aggressive
treatment, and for
patients with
lesions that have
not responded to
other laser
treatments. The
laser is also
indicated for the
reduction of red
pigmentation in
hypertrophic and
keloid scars where
vascularity is an
integral part of the
scar. Treatment of
wrinkles. | | | | |
10
11
In reference to the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and the information provided on the device comparison table and performance test results, the Yerim engineering Co., Ltd. believes that the ORION is substantially equivalent to the predicate device, Family of Altus Medical Modified CoolGlide Aesthetic Lasers (K014040, Altus Medical, Inc.), Cynosure Apogee Elite Laser (K034030, Cynosure, Inc.) and CLARITY LPC Laser System (K130199, Lutronic Corporation). ORION has the same intended use, performance specifications, and similar operational characteristics as the predicate devices. Performance data supports that the device is substantially as safe and effective as the predicate devices for its intended use. Therefore, ORION may be found substantially equivalent to its predicate devices.
Conclusion: 9.
Based on the testing results, YERIM ENGINEERING Co., Ltd. concludes that the ORION is substantially equivalent to the predicate device.