Royal Me
Soft Tissue injectable Implant
ROYALME
Soft Tissue injectable Implant
Product volume
50
100
Particle Size
0.75 ml
3 ml
Intended use
Device is intended to be used for intradermal and subcu-
taneous implantation to fill skin depressions as to restore
and enhance soft tissue volume.
taneous implantation to fill skin depressions as to restore
and enhance soft tissue volume.
It is recommended to be used for reconstructive purposes in the treatment for morphological asymmetry.
Device characteristics
Injectable PLA (Poly-D,L lactic Acid Filler is a white solid which is lyophilized mixed with Injectable PLA (Poly-D,L lactic Acid) and HA(Sodium Hyaluronate).
When used it is suspended in sterilized distilled water and made into a gel state, which can be injected into a syringe. When injected into wrinkles on the face, PLA micro-particles temporarily improve wrinkles by being physically filled subcutaneously. HA is used as a carrier to help inject the micro-particles into the syringe.
How to use
Predicted side effects
How to use
Check the packaging of the product for damage.
Check for deformation or foreign matter on the product.
Be sure to read the instructions before use.
Perform product suspension under aseptic conditions without microbial contamination.
Remove the vial's aluminum cap and wipe the rubber stopper with disinfectant.
Connect 18G sterile needle and inject sterilized distilled water into the vial.
Model
ROYALME 50
ROYALME 100
Sterile water for injection
0,75ml
3ml
Mix sterilized distilled water with a product for 3 minutes with a vortex mixer.
Wait for 5 minutes and mix again for 3 minutes with a vortex mixer.
Check the condition of the product and repeat step 8 two or three times to suspend.
Prepared products should be used immediately, and
any remaining product should be discarded.
any remaining product should be discarded.
Immediately before use, wipe the rubber stopper with
a disinfectant. Connect the 18G sterile needle to a 1ml
sterile syringe and take 0,8~1,2ml of the product.
a disinfectant. Connect the 18G sterile needle to a 1ml
sterile syringe and take 0,8~1,2ml of the product.
Connect a 25gauge sterile needle (or 25G sterile cannula
needle) to the syringe containing the product. Then
inject the product into the patient's facial wrinkles.
needle) to the syringe containing the product. Then
inject the product into the patient's facial wrinkles.
How to use
Predicted side effects
Predicted side effects
Injection site reaction
a) Hemorrhage
b) Pain
c) Induration
d) Swelling
b) Pain
c) Induration
d) Swelling
Immune system abnormality
a) Hypersensitivity Angioedema
b) Skin sarcoidosis
b) Skin sarcoidosis
Inflammation and Infection
a) Injection site infection including cellulitis
b) Staphylococcal infection
c) Abscess
b) Staphylococcal infection
c) Abscess
Skin and subcutaneous tissue abnormalities
a) Bruising
b) Hematoma
c) Atrophy, Skin hypertrophy
d) Erythema
e) Urticaria
f) Telangiectasis
g) The papules of subcutaneous are mostly invisible. It is
usually diagnosed by hand but there are no symptoms.
h) Visible nodules, including nodules of periorbital.
can occur and may be accompanied by inflammation
or discoloration. Nodules appearing after injection
can be minimized through proper use.
i) Subcutaneous nodules may appear late and last
(within 1 to 14 months after injection) for up to two
years: It may be necessary to remove the nodules
by intralesional corticosteroid therapy or surgically.
j) Granuloma
b) Hematoma
c) Atrophy, Skin hypertrophy
d) Erythema
e) Urticaria
f) Telangiectasis
g) The papules of subcutaneous are mostly invisible. It is
usually diagnosed by hand but there are no symptoms.
h) Visible nodules, including nodules of periorbital.
can occur and may be accompanied by inflammation
or discoloration. Nodules appearing after injection
can be minimized through proper use.
i) Subcutaneous nodules may appear late and last
(within 1 to 14 months after injection) for up to two
years: It may be necessary to remove the nodules
by intralesional corticosteroid therapy or surgically.
j) Granuloma
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