CHARGE CODE: NO_510KFD&C Act Section 510(k)Severity Weight: 8/10

✓ Form FDA 766 Relabeling Eligible

Adulterated / Misbranded Device: Lacks cleared Premarket Notification 510(k)

Statutory & CFR Citation: 21 U.S.C. § 360(k) • 21 U.S.C. § 351(f)(1)(B) • 21 CFR Part 807 • Associated Import Alert 89-08

Plain-English Importer Translation:

A Class I/II medical or aesthetic device was shipped to a US port without a valid FDA 510(k) clearance number or establishment registration.

Typical Port Detention Window

18–32 calendar days

Estimated Defense / Lab Cost

$4,000 – $11,000 (Device regulatory counsel & FURLS remediation)

Primary Import Alert Trigger

Import Alert 89-08

Form FDA 766 Relabeling / Reconditioning Playbook

ELIGIBLE IN SPECIFIC CASES: If a general wellness or Class I 510(k)-exempt device was detained solely because promotional claims crossed into Class II medical indications (e.g., an LED face mask claiming 'medical acne surgery recovery'), Form FDA 766 can be used to relabel it as a general wellness/cosmetic appliance.

Step-by-Step CBP & FDA ITACS Response Sequence:

1Cross-check the declared 3-letter FDA Product Code and CFR regulation number against FDA's Product Classification database.
2If the device already holds a valid 510(k) (PM#), submit an amended CBP ACE entry with the correct Affirmation of Compliance codes (PM#, FEI, DEV, LST).
3If detained due to over-reaching clinical claims on a 510(k)-exempt Class I or General Wellness product, file Form FDA 766 to replace manuals and outer boxes under FDA guidance 'General Wellness: Policy for Low Risk Devices'.
4If the device is genuinely a Class II invasive/energy device lacking a 510(k), file CBP Form 3499 to re-export immediately before liquidated damages accrue.

Private Lab Packet (PLAP) & Importer Checklist

Required Analytical / Regulatory Protocol:

Regulatory 510(k) substantial equivalence & FURLS Establishment Registration verification (no wet-lab testing required).

Pre-Shipment & Post-Detention Verification Checklist:

Verify the manufacturer's Establishment Registration & Device Listing (FEI number) in FDA FURLS.
Confirm whether the device claims fall under a 510(k)-exempt product code.

Historical OASIS Enforcement Precedents

Overseas Suppliers Cited for NO_510K (2)

Shenzhen, Guangdong (Bao'an), China • FEI 3016729104

Shenzhen MedOptic Photon Technology Co., Ltd.

100/100

Entry #W94-9182041-6 (2026-10-03)Port: Los Angeles

Dual-Wavelength 633nm/830nm Clinical LED Phototherapy Mask

Disposition: Released After Form 766 Relabeling • Value: $142,000

Entry #W94-8940122-4 (2026-07-11)Port: Miami

Fractional RF Microneedling Aesthetic Console (Model MP-900)

Disposition: Refused & Exported • Value: $98,500

Class I/II Medical, Dental & Aesthetic Devices Full Supplier Dossier

Tijuana, Baja California, Mexico • FEI 3014920188

Tijuana Baja MedTech Assemblies S.A. de C.V.

24/100

Entry #W94-8501920-2 (2025-10-15)Port: Los Angeles

Sterile Ultrasonic Dental Scaler Handpiece Tip Kit

Disposition: Released After Form 766 Relabeling • Value: $31,500

Class I/II Medical, Dental & Aesthetic Devices Full Supplier Dossier

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Full 5-year OASIS refusal history for Shenzhen MedOptic Photon Technology Co., Ltd. + category peers
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Get an automated Slack/Webhook JSON payload and email alert within 15 minutes whenever FDA OASIS logs a new detention, Import Alert Red List addition, or Warning Letter for Shenzhen MedOptic Photon Technology Co., Ltd. before you wire your 70% balance payment.

TIER 3 • URGENT US FDA COMPLIANCE COUNSEL DISPATCH (CPL VERIFIED)

Respond-By Deadline Priority Triage

Shipment Detained by FDA or Placed on Import Alert? Request Free 24h Detention Evaluation from Licensed US FDA Compliance Counsel

When FDA issues a Notice of FDA Action (Detention), importers typically have only 10 to 20 business days to file a Form FDA 766 relabeling application, submit an accredited private laboratory packet (PLAP), or petition for Import Alert Red List removal before CBP orders refusal and liquidated damages.

Your Full Name & Role (Required)

Include your name and title (e.g., “Sarah Chen, VP Supply Chain”).

Please provide your full name (at least 2 characters).

Work Email for 24h Legal Memo (Required)

Used strictly to deliver your conflict-free 24h FDA detention evaluation.

Please enter a valid corporate email address.

Importer Website or Amazon/Shopify Store URL (Required)

Include https:// so counsel can pre-screen product Intended Use claims.

Please enter a valid URL starting with https:// or http://.

CBP Entry Number or Supplier FEI # (Required)

Format: 10-digit FEI (e.g., 3016729104) or 11-char CBP Entry # (e.g., W94-8829104-3).

Enter a 5–24 character alphanumeric FEI number or CBP Entry number.

US Port of Detention

Select the FDA District / Port holding the cargo.

Primary Cited FDA Charge Code

Charge listed on your Notice of FDA Action.

Commercial Cargo Value at Risk

Determines Form 766 vs. PLAP economic viability.

Notice of FDA Action Summary & Respond-By Date (Optional)

Describe whether cargo is currently on hold in ITACS, whether private lab sampling has started, or if you need an Import Alert removal petition.

🔒 Confidential submission • Zero upfront cost for 24h detention evaluation • Matched with licensed US FDA / Customs attorneys.

Charge Code NO_510K FAQ

What does FDA Charge Code NO_510K (FD&C Act Section 510(k)) mean on a Notice of FDA Action?

Adulterated / Misbranded Device: Lacks cleared Premarket Notification 510(k). In plain English: A Class I/II medical or aesthetic device was shipped to a US port without a valid FDA 510(k) clearance number or establishment registration.