DEVOLUX® PLUS PLLA Injection Instruction Manual

Please be sure to read the instructions carefully before use and follow the directions.

Devolux® Plus PLLA Injection Composition

Each vial contains:

Poly-L-lactic acid                    180mg

Hyaluronic acid                      31mg

Mannitol                          183mg

Sodium carboxymethyl cellulose         6mg

Targets

Face(Forehead, Temple, Tear through, Cheekbone, Cheek, Nasolabial fold) , Hand, Neck, Strentch marks, Vagina, Breast, Buttocks

Mode of action

Devolux® Plus is the first semi-permanent filler made up of PLLA and hyaluronic acid designed with Grancross Technology™. Hyaluronic acid (HA) is a naturally occurring substance that delivers volume to the skin. Poly-L-lactic acid (PLLA) is a biocompatible, biodegradable, synthetic polymer.which is a derivative of the alpha hydroxy acid family. PLLA works deep within the skin to help stimulate the skin’s own natural collagen production. Devolux® Plus works to replace and reinforce the skin's basic collagen structure, restoring facial contour, smoothing out shallow to deep wrinkles, and the naturallooking results can last up to 3 years.

Process of taking effect

After the injection, the hyaluronic acid in Devolux® Plus and other dissolved suspensions immediately fill the depressed defects, and at this time, the wrinkles and depressions are filled. Within 15 days of the treatment, the hyaluronic acid propped up the depressions, and the PLLA molecules were absorbed by the body. After 30 days post-injection, Devolux® Plus stimulates the underlying skin to rebuild collagen structure and collagen production, the improvement becomes progressively noticeable, but deeper depressions and wrinkles may require further treatment.

Reconstitution method:

1. Add saline water 10 ml

2. Mix for 30min-1hour

3. Add Lidocaine 2ml

4. Shake before injection. Recommended needles: 25G-27G sharp needles, or 23G-25G blunt needles.

Treatment level

Between the subdermis and the superficial fat pad.

Treatment course

2 times treatment is a session.

The second treatment is 1-1.5 months after the first treatment.

Method of use

Forehead

•  Dosage: 2.5-10ml

• Application Level: Galeal layer - This layer is loose,has no nerves and blood vessels.and does not bruise.

•  Note: If the amount is too large, the water will flowdown.

Temples

•  Dosage: 2.5-5ml

•  Application Level: Subcutaneous fat layer -veryloose layer, this is the avasculararea, very good treatment.

•  Note: Withdraw the needle and press until themedicine is evenly dispersed, then use ablunt needle to spread PLLA at thesubcutaneous fat evenly, and press evenly.

Cheekbones

•  Dosage: 2.5-5ml

•  Application Level: Subcutaneous fat layer, on theSMAS fascia layer, do not breakthrough the SMAS fascia layer.

Tear Troughs

•  Dosage: 2.5-3ml

•  Application Level: Close to the periosteum.

Nasolabial Folds

• Dosage: 2.5-3ml

• Application Level: Sharp needles are used in thepyramid style, and there are moredrug delivery points near theperiosteum layer.

•Note: Tr not to make exaggerated expressions forthree davs after iniection. to void musclebacklog and spread the medicine. upward Inaddition.it is recommended to use sharpneedles vertically for the nasal base.

Cheeks

•  Dosage: 0.3-1ml on one side

•  Application Level: Galeal layer - This layer isoose, has no nerves and bloodvessels, and does not bruise.

•  Note: It is recommended to use blunt needles flatlyin multiple layers, subcutaneous, fat layer, fascia layer, subfascial tissue and periosteum.

Hands

•  Dosage: 10-20ml on one side

•  Application Level: Subcutaneous layer

Neck

•  Dosage: 1.5-3ml per wrinkle

•  Application Level: 30G sharp needle or 27G bluntneedle, between subdermal and platysma muscle.

•  Note: Mixing ratio: Add 15ml sterile water and 2ml Lidocaine.

Stretch Marks

•  Dosage: 20ml-30ml

• Application Level: At the obvious part of the fractured layer. The sharp needle is insert edvertically into the deep dermis.

•  Note: Do not inject at the fat layer, Mixing ratio; Add 15ml sterile water and 2ml Lidocaine.

Vagina

•  Dosage: 2-3ml on oneside of vagina1ml on one sideof labia majora

• Application Level: On the mucous membrane of bothsides of the vagina, by multi-pointinjection or one-point large volume iniection.

•  Note: Do not insert the needle deeply.

Postoperative nursing

• Apply ice to the treated area several times over 24 hours to help reduce swelling.

• Self-massage the treated area starting on the 4th day after the procedure, continue for 3 days, massaging 3 times a day, for 3 minutes each time.

• Avoid exposure to sunlight and UV lamps.

Contraindications

• Relative contraindications: autoimmune diseases, systemic lupus erythematosus, vitiligo.

• Strict contraindications: severe scar constitution.

• Individuals under the age of 18 should not use it.

• Patients with a history of allergies to any ingredient of the product should not use it.

• Patients allergic to lidocaine or other amide-type local anesthetics should not use it.

• Patients with a history of severe systemic allergic reactions, or those who have had or have multiple severe allergies, should not use it.

• Do not use this product when the area to be treated, or a nearby area, has an active disease, such as inflammation (skin eruptions, such as boils, acne, rashes, or hives), infection, or tumors, until the condition is under control.

Warning

• Devolux® Plus should only be used in the deep dermis, bone, or subcutaneous tissue.

• The nurse with the station should ensure that the medicine isevenly dissolved.Moderately oscillate for 5 minutes beforetreatment, observe the state of the drug in the needle tube, itmust be evenly distributed, and cannot be injected in a pre.cipitated state

• Be sure to stop the administration before the needle is with-drawn, and focus on massaging at the needle entry point tospread the medicine, so as to avoid excessive drug residue atthe needle entry point and increase the risk of nodules..

• This product must not be injected into muscles or veins. Injection into or near blood vessels can cause local superficial death and scarring, which is caused by damage, blockage, or injury to the vessels. Special care should be taken if the patient has had surgery in the area to be treated. Areas with limited blood flow from collateral vessels may increase the risk of ischemia. Aspiration is recommended before injection.

• Accidental placement of soft tissue fillers into facial blood vessels may lead to embolism, vascular occlusion, ischemia, necrosis, or infarction of the implanted site or the area supplied by the affected vessels. Rare but serious adverse events include temporary or permanent visual impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and potential damage to underlying facial structures. If any of the following symptoms occur, stop the injection immediately, including changes in vision, stroke-like symptoms, skin whitening, or unusual pain during or shortly after treatment. The patient should receive immediate medical care and be evaluated by a physician to determine if the injection was into a vessel.

• Pay attention not to excessive treatment, just reach the idealstate, do not overdose, reduce the occurrence of swelling.

• Devolux® Plus vials are for single-patient, single-use only to avoid contamination. Vials should not be reused or resterilized. Dispose of immediately after use. Do not use if the packaging or vial has been opened or damaged.

• The powder must be reconstituted with sterile water for injection.

F＆Q

▪ How to inject to get a better effet?

The blunt needle is stripped, and the suspension isinjected widely with multiple layers and multipletunnels. The blunt needle peeling method is easierthan the sharp needle treatment, and the treatmenteffect will be better, the tissue swelling caused bythe peeling will generally be relieved after 72 hours,and the patients can also be recommended to takethe "Caomuxiliu Infusion Tablet" produced in Japan,also known as "Eliminate". After injection, massage(use the palm root position) to make the productrelatively fixed in the interstitial space. Aftermassage, 20-30 units of botulinum toxin injection can beused to assist positioning.

▪ Can I exercise after the procedure?

You can resume exercise the next day. The product is stable, and the human body has a short recovery period after treatment. Do not wet the treated area for 6-24 hours post-treatment. The risk of infection mainly comes from the skin channel (needle hole) during treatment.

▪ What causes the product to clump? How should it be handled?

Long-term exposure to high temperatures during transport or storage, or violent shaking, may cause the product to clump. You can add saline and let it sit for 10 minutes to see the dilution effect; if there is still a lot of sediment, you can use the supernatant for treatment. If the doctor determines it cannot be used, you can provide, but not limited to: clear pictures of the suspension from multiple angles, packaging + batch number, time and place of use, and a brief description of the usage process. After confirmation by the company's designated quality control personnel, a replacement can be arranged.

▪ Can it be combined with photonic projects/BO?

It can be combined. It is recommended to do the youth needle first, and then photonic projects 4-6 months later (photonic projects generally last 30-40 minutes, and the temperature is high, while PLLA decomposes faster at 50-60 degrees Celsius, so if the youth needle is done first, followed by photonic projects, the effect of the youth needle will be compromised. If you want to do both at the same time, you can stagger the areas, or do the photonic project first, and after cooling the local skin for half an hour, proceed with Devolux treatment.

It can also be combined with BO treatment, as BO can block the transmission of information between nerves and muscles, which is more conducive to the fixation of PLLA.

▪ Can it be used for acne scar treatment?

Yes, generally 0.2-0.3ml per 1 square centimeter can be used.

▪ What to do if nodules and swelling occur?

Nodules can dissolve over time. Try not to treat and allow it to recover on its own if a reaction occurs.

▪ What type of lidocaine is used to dissolve PLLA?

Ordinary lidocaine is sufficient; adrenaline lidocaine should not be used.

Expiry time and storage conditions

Expiry time: 24 months

Storage conditions: Devolux® Plus should be stored at room temperature and away from heat sources (not exceeding 30°C). Once reconstituted, Devolux® Plus can be stored in the refrigerator (2-8°C) or at room temperature not exceeding 30°C for up to 72 hours.

If the product has exceeded the manufacturing date and shelf life indicated on the packaging, or if the batch number is missing or difficult to identify, please do not use it.

Do not freeze.

After use, the treatment syringes and needles may pose a potential biological hazard. They should be disposed of in accordance with approved medical practices and applicable local regulations.

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