FDA Registration
Active
🇭🇰 Hong Kong
Fourstar Group
Reg #: 3007838093
·
FEI: 3007838093
·
Expires 2026
Products
49
Proprietary Names
8
Establishment Types
1
Classifications
49
Registration Details
- Registration Name
- Fourstar Group
- Registration Number
- 3007838093
- FEI Number
- 3007838093
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 41 Main Yue St, Unit A, 8/F, Kaiser Estate Phase 1, Kowloon
- City
- Kowloon
- Country
- HK
Regulatory Submissions
- 510(k) Number
- K153597
Owner / Operator
- Firm Name
- FOURSTAR GROUP INC.
- Operator Number
- 8043323
- Address
- L101 Teva Cultural & Creative Plaza, No. 1010, Qiao Xiang Road, Futian District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518034
- Country
- CN
- Correspondent
- Ted Conlon
US Agent
- Business Name
- Fourstar Group USA, Inc.
- Contact Name
- Edward Conlon
- Address
- 189 Main St Ste 31
- City
- Milford
- State
- MA
- ZIP
- 01757
- Country
- US
- [email protected]
- Phone
- 508 4737388 ext. 2004
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Adaptor, Grooming | ILW | Class 1 | Physical Medicine | No | 2022-07-27 |
| Reader, Bar, Ophthalmic | HJY | Class 1 | Ophthalmic | No | 2021-05-18 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2018-04-12 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2018-04-12 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2022-04-07 |
| Finger Cot | LZB | Class 1 | General Hospital | No | 2023-04-21 |
| Joint, Ankle, External Brace | ITW | Class 1 | Physical Medicine | No | 2018-04-12 |
| Enzyme Immunoassay, Amphetamine | DKZ | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Methadone | DJR | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Barbiturate | DIS | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Cocaine And Cocaine Metabolites | DIO | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-04-07 |
| Enzyme Immunoassay, Benzodiazepine | JXM | Class 2 | Clinical Toxicology | No | 2023-04-07 |
| Mask, Surgical | FXX | Class 2 | General, Plastic Surgery | No | 2020-04-29 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2020-04-04 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2019-03-22 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2019-03-22 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-05-28 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-06-01 |
| Tampon, Menstrual, Unscented | HEB | Class 2 | Obstetrics/Gynecology | No | 2025-03-04 |
| First Aid Kit With Drug | LRR | Class N | Unknown | No | 2024-12-23 |
| Applicator, Ent | KCJ | Class 1 | Ear, Nose, Throat | No | 2023-05-08 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2011-12-20 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2023-01-17 |
| Floss, Dental | JES | Class 1 | Dental | No | 2005-12-12 |
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2018-04-12 |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | Class 1 | Ear, Nose, Throat | No | 2025-06-17 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2026-03-02 |
| Protector, Hearing (Insert) | EWD | Class U | Unknown | No | 2022-07-28 |
| First Aid Kit Without Drug | OHO | Class 1 | General, Plastic Surgery | No | 2024-12-23 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2011-10-07 |
| Toothbrush, Manual | EFW | Class 1 | Dental | No | 2005-12-12 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-07 |
| Dressing, Wound, Hydrophilic | NAC | Class 1 | General, Plastic Surgery | No | 2022-07-27 |
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2009-08-26 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2026-06-08 |
| Vinyl Patient Examination Glove | LYZ | Class 1 | General Hospital | No | 2020-04-04 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2025-12-04 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2006-09-01 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-04-03 |
| Ring, Teething, Non-Fluid Filled | MEF | Class 1 | Dental | No | 2022-07-26 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2017-04-25 |
| Gown, Isolation, Surgical | FYC | Class 2 | General, Plastic Surgery | No | 2020-04-29 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 2022-07-27 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2018-04-12 |
| Support, Arm | IOY | Class 1 | Physical Medicine | No | 2018-04-12 |
Proprietary Names
Magnifier
Swim Mask
TheraPlus
Cool Bandage
Cool Patch
COLD / HOT PAD
TOOTHBRUSH
MASSAGER
Establishment Types
Export Device to the United States But Perform No Other Operation on Device