Chinese Optical Manufacturer Gains Approval to Supply Custom Contact Lenses in the United States

2026-09-04 companies

Washington, Friday, 4 September 2026.
Constar Factory secured U.S. FDA clearance for contact lenses, letting American brands launch private labels immediately and reducing standard minimum order requirements from 10,000 to 1,000 pairs.

Regulatory Breakthrough for U.S. Market

On September 4, 2026, optical manufacturer Constar Factory announced it has received 510(k) clearance from the U.S. Food and Drug Administration for its contact lens OEM solutions [1]. This regulatory approval allows the company to offer private-label contact lens production, custom manufacturing, and wholesale distribution to American importers and brands [1]. The clearance classifies the products as Class II medical devices subject to mandatory U.S. FDA (CDRH) regulatory compliance [2]. Constar Factory, based in Baiyin, Gansu, China, leverages over 40 years of industry experience to support US-based importers and distributors [1]. This development is expected to expand supply chain options for U.S. vision care distributors and private-label optical retailers [1]. Importing contact lenses into the U.S. requires both manufacturers and importers to complete FDA establishment registration and device listing [2]. Products must adhere to 21 CFR Part 801 labeling requirements, including prescription-only status warnings [2]. All contact lenses imported into the United States require FDA 510(k) clearance, a legal requirement enforced by U.S. Customs and Border Protection and the FDA [2].

Lowering Barriers to Entry

The US contact lens market is valued at over $4.5 billion annually with a 5% year-over-year growth rate [1]. Constar Factory provides a low minimum order quantity (MOQ) of 1,000 pairs per design, contrasting with traditional industry standards of 10,000+ pairs [1]. This shift represents a -90 percent reduction in the standard minimum order threshold [1][4]. The company offers FDA 510(k)-cleared soft contact lenses including daily, monthly, colored, cosmetic, and toric varieties [1]. These products are manufactured under ISO 13485 quality systems and CE MDR certification [1]. Constar claims to be the only contact lens manufacturer in China holding FDA, CE 0197, and ISO 13485 certifications simultaneously [4]. Private labeling is permitted if the manufacturer holds FDA clearance and the labeler completes proper FDA registration and device listing per 21 CFR Part 801 [2]. US importers can begin distributing contact lenses immediately without waiting for their own FDA clearance process [1]. Our existing 510(k) clearance covers the products we manufacture, which means our partners can focus on building their contact lens brand while we handle the regulatory complexity [1].

Streamlining the Supply Chain

The standard import timeline spans approximately 55 days from initial verification to shipping and customs [2]. The process includes initial verification (Days 1–2), inquiry submission (Day 1), sample approval (Days 1–10), production and QC (Days 11–45), and shipping/customs (Days 45–55) [2]. Constar offers a 55-day delivery timeline from order confirmation to U.S. delivery and commits to responding to sourcing proposal requests within 12 hours [2][alert! ‘Sourcing proposal response time requires verification’]. Estimated costs per 1,000 pairs of contact lenses range from $1,500 to $3,000, comprising OEM product costs, air freight, customs duties, FDA Prior Notice fees, broker fees, and insurance [2]. Mandatory documentation for importers includes an import bond, commercial invoice, packing list, bill of lading/airway bill, and FDA Prior Notice [2]. Manufacturers must provide the 510(k) clearance letter, ISO 13485 certification, and biocompatibility test reports (ISO 10993) [2]. Importing non-FDA cleared contact lenses carries severe penalties, including product seizure, import alerts, warning letters, and potential criminal prosecution [2]. Contact lenses are prescription-only medical devices in the United States, and end consumers must have a valid prescription from a licensed eye care professional [2].

International Certification Standards

Globally, contact lenses are classified as Class IIb medical devices in the United Arab Emirates, requiring mandatory registration with the Ministry of Health and Prevention [3]. The UAE beauty and personal care market is projected to reach $4.5 billion by 2027, with contact lenses identified as a high-growth segment [3]. In the United Kingdom, the optical market is valued at £1.2 billion with an annual growth rate of 8% [5]. Under UK MDR 2002 regulations, contact lenses are classified as Class I low-risk medical devices, necessitating mandatory MHRA registration [5]. All overseas manufacturers placing medical devices on the UK market must appoint a UK-based Responsible Person to comply with UK MDR 2002 [5]. CE marking is currently accepted for import into the UK under an extended recognition period that expired on June 30, 2025 [5][alert! ‘Status overdue/expired as of 2026-09-04’]. Constar Factory operates as a private-label contact lens manufacturer in China, currently holding FDA, CE 0197, and ISO 13485 certifications [4]. Standard production timelines range from 25 to 50 days depending on the product type [4]. Physical samples for qualified inquiries are provided with a typical delivery window of 7-10 days, and sample costs are credited toward the initial production order [4].

Sources

Contact Lenses FDA Clearance