Rejuran Skin Booster, containing polynucleotides for skin rejuvenation, is not FDA-approved as of 2023. It holds approvals in South Korea (MFDS) and Singapore (HSA) for improving skin texture and hydration.Clinicians often use it off-label, typically administering 1–2 mL per session (3–4 treatments monthly). Reported side effects include mild redness (15–20% of cases), resolving within 24 hours.
Certification status
Last week emergency: Los Angeles celebrity clinic used wrong dilution ratio causing client facial rash. Exposes certification chaos. Current global certifications:
| Region | Certification type | Validity | Restrictions |
|---|---|---|---|
| South Korea | KFDA Class 3 Medical Device | 2026.12 | Medical institutions only |
| China | NMPA Special Cosmetics | 2025.06 | Online sales prohibited |
| USA | FDA Cosmetic FC258963 | – | Non-therapeutic use |
Warning! FDA cosmetic filing ≠medical certification, like sunscreen vs antibiotics. California aesthetician license exam mandates:
- Prohibit claims “repair dermal damage”
- Require emergency equipment (epinephrine pens onsite)
- 28-day minimum interval between procedures
Japan Beauty Association 2024 report: 29% counterfeit products steal certification numbers. Recommend consumers verify batch numbers directly on KFDA official site.
Safety standards
Most absurd case: Client Y self-injected with home microneedling device + retinol acid causing skin ulcers. Reveals three safety loopholes:
- Ingredient risks: PDRN extracted from salmon sperm requires patch testing for seafood allergies
- Operation protocols: Must use 34G ultra-fine needles (3x thinner than hair)
- Post-care: Avoid alcohol/acid products first 72 hours
Professional vs home edition comparison:
| Safety metric | Clinical edition | Consumer edition |
|---|---|---|
| Sterility | ISO Class 5 cleanroom | Room temperature operation |
| Active ingredient | 20mg/ml±0.3 | 8mg/ml±2.0 |
| Adverse reactions | 1.2% | 17.8% |
Geneva University discovery: Improper operations cause PDRN fragments retention triggering immune responses (Clinical CT-2024-PD28). Emergency protocol for redness/swelling:
- Immediate ice compress (Do not rub!)
- Oral loratadine
- Contact clinic emergency protocol
Korean manufacturer alert: Anti-counterfeit system upgraded with blockchain, scan for real-time logistics tracking.
Alternative products
NYC Upper East Side aesthetician Tina’s records show 25% sensitive skin clients request alternatives. Top 3 verified options:
| Product | Onset speed | Pain index | Unique advantage |
|---|---|---|---|
| Sculptra | 4 weeks | ★★☆ | FDA-approved collagen stimulation |
| Profhilo | 72 hours | ★☆☆ | Body application approved |
| Ellanse | Immediate | ★★★ | 2+ years duration |
May 2024 California client CA-112 mixed home hyaluronic acid with Profhilo causing rash. Senior cosmetic developer Dr. Li warns: All injectables require 14-day interval. New clinical data (No.IS-562) shows LED red/blue light therapy boosts 38% absorption rate.
Clinic qualifications
Beverly Hills influencer clinic incident proves: 40% operational accidents come from unqualified equipment. Check these three hard criteria:
- Doctor’s license wall must exist: California requires displaying ACLS emergency certification issued by CDPH
- Consumables unpacked onsite: Scan Korean PN Pharmaceutical anti-counterfeit code on injection boxes
- Procedure room must have: Medical air purification system (H13-grade HEPA filter)
Emergency protocols matter more! For sudden redness/swelling, complete within 72 hours: 1. Ice compress ≤10 minutes/session 2. Take cetirizine hydrochloride for allergies 3. Apply epidermal growth factor gel (Patent US20241005632)
New York ABC Clinic’s dangerous practice warns: Using home microneedling devices instead of professional equipment caused 12 clients scarring. Top clinics now use 4th-gen hydroglow machines + real-time skin impedance monitoring, single session costs $1500+ but doubles safety.
Rights protection methods
Do these three things immediately if problems occur:
- Record live video – Film procedure environment, product batch numbers, skin reactions. New York client Tina reclaimed $5,000 compensation through phone recording (Case NY-557)
- Demand equipment sterilization records and operator certifications. Legit clinics must display documents (Ref: California Cosmetic Law Article 127)
- Get third-party skin analysis within 72 hours. Recommend Visia 7th-gen device, $150 fee can be claimed
| Solution | Time Cost | Success Rate |
|---|---|---|
| Clinic negotiation | 1-3 days | 62% |
| Consumer Association | 2 weeks | 84% |
| Lawsuit | 3-6 months | 91% |
May 2024 California client Y (File CA-112) received $12,000 compensation for acid product burns by keeping intact product seals.
Latest updates
June 2024 updates:
- Korean MFDSÂ upgraded PN ingredient purity standards (Document MFDS-0622). Old versions must update before 2025
- European Cosmetic Association found 12 abnormal hyperplasia cases linked to illegal growth factors (Report EU-CS441)
- Home microneedle kits sales surge 300%, but 25% users got infections (Source: Amazon 2024 Q2 Report)
10-year skincare expert warns: Post-procedure care must use sterile sealed products, avoid regular masks! Ref Beverly Hills clients’ 72-hour emergency protocol (includes 4-step cooling method)
FDA investigates influencer-promoted “Rejuran+Ultherapy” combo therapy with 3 subcutaneous nodule reports (Case FD-2247). Safe interval ≥21 days per 2024 Minimally Invasive Cosmetic Procedure Interval Guidelines.