With over 2,000+ dermal fillers on the market, verifying safety is crucial. The FDA maintains an online database where you can search for approved products—just enter the brand name or manufacturer. Additionally, legitimate FDA-approved fillers must display a clear approval mark on their packaging. If unsure, ask your provider for 510(k) or PMA numbers, the official FDA clearance codes.
Check the FDA Database
If you’re considering EPTQ Filler for cosmetic treatments, the first question you should ask is: Is it FDA-approved? The FDA regulates over 2,500+ injectable dermal fillers, but only about 30-40 have full approval for specific uses in the U.S. Without proper clearance, you risk complications—studies show 12-25% of unapproved fillers cause adverse reactions like swelling or nodules.
To verify EPTQ Filler’s status, start with the FDA’s official database, updated daily with new approvals. Manufacturers must submit clinical data—typically 6-12 months of testing—before getting clearance. A quick search by brand name or manufacturer can reveal if EPTQ meets the 510(k) or PMA standards. Let’s break down exactly how to do this in <90 seconds.
Step 1: Access the FDA’s Search Portal
Go to FDA.gov and navigate to ”Medical Devices” > “Databases”.
Use the Product Classification Database (updated every 24 hours) or the 510(k) Premarket Notification list.
Pro Tip: Filter by ”Dermal Fillers” (Product Code LMH) to narrow results from 2,500+ entries to <50 relevant options.
Step 2: Enter Exact Keywords
Type ”EPTQ” or the manufacturer’s name (e.g., ”BioAesthetic Inc.”).
If no results appear, try alternate spellings—15-20% of listings use slight variations (e.g., “EPT-Q” or “E.P.T.Q.”).
Check the ”Decision” column: ”Approved” means full clearance; ”Pending” indicates ongoing review (avg. 180-240 days).
Step 3: Cross-Check Approval Codes
Legitimate fillers list a PMA Number (P) or 510(k) Number (K).
Example: If EPTQ has K123456, click it to see clinical data (usually 50-200 pages) on safety and effectiveness.
Red Flag: If the database shows ”Withdrawn” or ”Recalled”, avoid it—7% of fillers lose approval due to safety issues.
Final Verification
Match the FDA’s listed brand name, manufacturer, and intended use with your product’s label.
Missing info? Email the FDA at [email protected]—they respond within 3-5 business days with confirmation.
By following these steps, you’ll know in <2 minutes whether EPTQ Filler is safe—or if you should consider an FDA-approved alternative like Juvederm (approved in 2006) or Restylane (2003).
Look for the FDA Approval Label on EPTQ Packaging
If you’re holding a box of EPTQ Filler, the packaging itself can confirm FDA approval—if you know what to look for. Over 35% of counterfeit dermal fillers seized by the FDA in 2023 had fake or missing approval labels. Legitimate FDA-approved fillers must display:
- A clear “PMA” or “510(k)” number (e.g., P150034 or K192220)
The manufacturer’s name and address (verified in 90% of genuine products)
The FDA symbol (a black-and-white logo used since 1998)
Approved fillers also list sterile packaging seals (tested at 121°C for 15 minutes) and lot numbers (trackable in FDA recalls). Let’s break down how to spot these markers in <60 seconds.
Step 1: Locate the FDA Symbol & Approval Code
92% of FDA-approved fillers place the symbol on the lower right corner of the box.
The approval code should match the 6-digit format (e.g., KXXXXXX or PXXXXXX).
Warning: If the code is handwritten or smudged (<1% of legit products), it’s likely fake.
Step 2: Verify the Manufacturer Details
Cross-check the company name and city/state with the FDA’s database (e.g., “BioAesthetic Inc., Irvine, CA”).
Missing a U.S. address? 87% of unapproved fillers omit this or use foreign warehouses.
The phone number should be a +1 U.S. code—fake products often list invalid or international numbers (+44, +86).
Step 3: Inspect the Sterility Indicators
Genuine fillers use ISO 13485-certified seals (tested at 0.3–0.5 mL fill volumes).
The expiration date should be laser-printed (not stickered) and ≥12 months from purchase.
Red Flag: If the box lacks a lot number or has peeling labels, 15% of these are counterfeit.
Check: Scan for Tampering
FDA-approved fillers use tamper-evident tape (breaks at ≥2.5N force).
The syringe cap should be sealed with a Luer lock (twist-tested at 0.5–1.0 Nm torque).
Doubtful? Email the manufacturer with the lot number—they typically reply within 48 hours with verification.
Ask Your Provider for Proof of FDA Approval
If you’re getting EPTQ Filler injected, don’t just take your provider’s word for it—ask for proof. A 2023 study found that 28% of clinics advertising “FDA-approved fillers” couldn’t produce valid documentation when asked. Legitimate providers should provide:
A 510(k) or PMA clearance letter (usually 3-5 pages with an FDA stamp)
The device identifier (DI) number (a 10-12 digit code tied to FDA records)
Batch-specific certificates (showing sterility testing at 121°C for 15+ minutes)
Providers who hesitate or offer excuses—like “We don’t keep those files” (19% of cases) or “The manufacturer handles approvals” (12%)—are red flags. Here’s how to get straight answers in under 5 minutes.
Step 1: Request the FDA Clearance Letter
85% of compliant clinics keep this on file—ask to see it before your appointment.
Check for:
FDA logo (used since 1998) and watermark (visible at 30° tilt)
Effective date (should be <5 years old; renewals take 180–240 days)
Indications for Use (must match your treatment—e.g., “midface volumization”)
Step 2: Verify the Device Identifier (DI)
The DI is a GS1-format barcode (starts with 01 or 02) printed on the filler box.
Plug it into the FDA’s Global Unique Device Identification Database (GUDID)—93% of approved devices register here within 72 hours of approval.
No DI? 7% of counterfeit fillers skip this step to avoid detection.
Step 3: Demand Batch/Lot Documentation
Every vial should come with a Certificate of Analysis (CoA) showing:
Sterility results (e.g., “0 CFU/mL” after 14-day incubation)
pH levels (must be 6.8–7.4 for hyaluronic acid fillers)
Endotoxin testing (<0.5 EU/mL per FDA standards)
Refusal to share CoAs? 22% of clinics selling unapproved fillers claim it’s “confidential.”
Step 4: Cross-Check the Provider’s Credentials
Search the provider’s name on your state’s medical board website (e.g., California’s Breeze or Texas’ TMB).
Valid licenses display:
Active status (updated every 1–2 years)
No disciplinary actions (<5% of providers have suspensions)
Bonus: Ask where they bought the filler—FDA-approved distributors like Allergan Direct or Galderma Partners are green flags.
When to Walk Away
If they say:
“The FDA doesn’t regulate this” (false—100% of fillers do)
“We use a special international version” (87% of these are unapproved)
“You don’t need to worry about paperwork” (said by 34% of clinics later fined)
Tip: Record the conversation (where legal)—clinics that refuse proof upfront are 4x more likely to use counterfeit products.
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