# Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) (K262752): 510(k) cleared for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.

**Predicate Speed & CAPA Advisory Opportunity Score:** 42/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262752 |
| Device | Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) |
| Applicant | Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. |
| Specialty / panel | General, Plastic Surgery |
| Product code | OHS |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-08-03 |
| Decision date | 2026-10-23 |
| Review time (days) | 81 |
| Third-party review | No |
| Applicant location | Shenzhen, CN |

## Why this score
- Fast 81-day review: this device is a strong predicate for similar products.
- Posted 13 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K262752). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.