Shenzhen, Guangdong (Bao'an), China (CN)FEI: 3016729104DUNS: 547910288Class I/II Medical, Dental & Aesthetic Devices

Shenzhen MedOptic Photon Technology Co., Ltd.

Raw CBP/OASIS Entity String: SHENZHEN MEDOPTIC PHOTON TECHNOLOGY CO., LTD.

FSVP Lead Auditor Note: OEM manufacturer of home-use LED red-light therapy masks, IPL hair removal handsets, and RF fractional microneedling devices. Detained when white-label buyers declare Class I exempt codes while shipping Class II energy devices without a valid 510(k) PM# or with clinical wound-healing claims.

Primary US Port

Los Angeles

Last FDA Inspection

2026-06-05

OAI (Official Action Indicated)

Detained Cargo Value

$316,500

Across 3 holds

Est. US Containers/Yr

~195 TEUs

CBP ACE Bill of Lading

Composite Procurement RiskCRITICAL_IMPORT_ALERT

100/ 100 Risk Score

5-Year Import Refusals:3

Active Warning Letters:1

FDA Enforcement Recalls:1

Red List — Import Alert 89-08 (Device Without Cleared 510(k))

Shipment Held? Request 24h Legal Review

6-Month Port Detention vs. Cleared Entry Velocity (Los Angeles)

Source: CBP ACE Manifest + FDA OASIS Refusal Feed

May 2026

3 Held14 Cleared

Hold Rate: 18%

Jun 2026

4 Held12 Cleared

Hold Rate: 25%

Jul 2026

6 Held9 Cleared

Hold Rate: 40%

Aug 2026

5 Held11 Cleared

Hold Rate: 31%

Sep 2026

4 Held13 Cleared

Hold Rate: 24%

Oct 2026

5 Held11 Cleared

Hold Rate: 31%

Dataset 1 of 3 • FDA OASIS Import Refusals

Historical Port Detentions & Refusal Dispositions (3)

Entry # & Date	Port	Detained Product & FDA Code	Charge Code & Import Alert	Cargo Value	Final CBP/FDA Disposition
W94-9182041-6 2026-10-03	Los Angeles	Dual-Wavelength 633nm/830nm Clinical LED Phototherapy Mask FDA Product Code: 89G	NO_510K Import Alert 89-08	$142,000	Released After Form 766 Relabeling
W94-8940122-4 2026-07-11	Miami	Fractional RF Microneedling Aesthetic Console (Model MP-900) FDA Product Code: 87I	NO_510K Import Alert 89-08	$98,500	Refused & Exported
W94-8611904-0 2026-01-24	Los Angeles	Home Cold-Laser Scalp Hair Regrowth Helmet FDA Product Code: 89G	UNAPPROVED_NEW_DRUG Import Alert 89-08	$76,000	Refused & Exported

Dataset 2 of 3 • CDER / CFSAN / CDRH Enforcement

FDA Warning Letters & Form 483 Citations (1)

CMS-681204 • Issued 2026-07-18Active / Open

CDRH Office of Product Evaluation and Quality (OPEQ)

Adulterated & Misbranded Aesthetic Energy Devices Lacking 510(k) Clearance

CDRH determined that Model MP-900 RF Microneedling units shipped under a general massager product code require Class II 510(k) clearance under 21 CFR 878.4400.

FD&C Act § 510(k)FD&C Act § 501(f)(1)(B)21 CFR § 820.30

Dataset 3 of 3 • RES Recall Enterprise System

5-Year US Market Recalls (1)

Recall #Z-1192-2026 (2026-04-10)Class II

Home IPL Sapphire Hair Removal Handset (Batch 2511-A)

Reason: Optical skin-contact sensor firmware glitch allowing flash emission without full skin contact.

Distribution Scope: 4,100 units

Plain-English Statutory Translation & Importer Action Plan

Cited FDA Charge Codes & Remediation Checklists for Shenzhen MedOptic Photon Technology Co., Ltd.

NO_510K (FD&C Act Section 510(k))Form FDA 766 Relabeling Eligible

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

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.

Importer Remediation 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.

Typical Hold: 18–32 calendar daysView Full NO_510K Form 766 Playbook →

UNAPPROVED_NEW_DRUG (FD&C Act Section 505(a))Form FDA 766 Relabeling Eligible

Unapproved New Drug: Cosmetic or Supplement making therapeutic disease claims

The product (often a skincare serum, device, or dietary supplement) uses medical or disease-cure claims on its packaging or website without an approved NDA/ANDA.

Importer Remediation Checklist:

Audit all product box copy, package inserts, and linked Shopify/Amazon URLs for therapeutic verbs ('cures', 'treats inflammation', 'heals acne').
File an FDA Relabeling Application (Form FDA 766) if the violation is purely on physical packaging.
Verify active ingredients against OTC Monograph compliance requirements.

Typical Hold: 14–28 calendar daysView Full UNAPPROVED_NEW_DRUG Form 766 Playbook →

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Full 5-year OASIS refusal history for Shenzhen MedOptic Photon Technology Co., Ltd. + category peers
21 CFR 1.505 Foreign Supplier Verification Program (FSVP) audit checklist tab

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Instant Supplier Detention Webhook & Email Alert Monitor

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.

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Importer Website or Amazon/Shopify Store URL (Required)

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

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CBP Entry Number or Supplier FEI # (Required)

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

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US Port of Detention

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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.

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Shenzhen MedOptic Photon Technology Co., Ltd. Compliance FAQ

Is Shenzhen MedOptic Photon Technology Co., Ltd. (FEI 3016729104) on an FDA Import Alert Red List?

Shenzhen MedOptic Photon Technology Co., Ltd. currently carries a Composite FDA Risk Score of 100/100 (CRITICAL_IMPORT_ALERT) in DWPERadar records with status: Red List — Import Alert 89-08 (Device Without Cleared 510(k)). Primary US port of entry is Los Angeles. Historical records are informational only and should be cross-checked on official FDA dashboards before CBP filing.

What are the main FDA Charge Codes cited against Shenzhen MedOptic Photon Technology Co., Ltd.?

Across the 5-year OASIS refusal dataset, Shenzhen MedOptic Photon Technology Co., Ltd. has been cited for NO_510K, UNAPPROVED_NEW_DRUG. Importers should review the statutory remediation checklists and Form FDA 766 eligibility before filing CBP entry.