FDA Registration
Active
🇺🇸 United States
Medtek Skin Care, Inc.
Reg #: 1318319
·
FEI: 1318319
·
Expires 2026
Products
5
Proprietary Names
13
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Medtek Skin Care, Inc.
- Registration Number
- 1318319
- FEI Number
- 1318319
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3 Depot St
- City
- HUDSON FALLS
- State
- NY
- ZIP
- 12839
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170187
Owner / Operator
- Firm Name
- MEDTEK Skin Care, Inc.
- Operator Number
- 1318319
- Address
- 3 DEPOT ST., P.O. Box 230
- City
- Hudson Falls
- State
- NY
- Postal Code
- 12839
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2018-09-05 |
| Light, Ultraviolet, Dermatological | FTC | Class 2 | General, Plastic Surgery | No | 2008-05-06 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2018-09-17 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2018-09-05 |
| Booth, Sun Tan | LEJ | Class 2 | General, Plastic Surgery | No | 2020-02-26 |
Proprietary Names
POLY Pro
Models 3200B and 4000B
UV Biotek 1200 - 4000 A thru B
Model 3200A
UV Biotek Single Panel Models 20B, 40B, 60B, 80B, 100B
UV Biotek Multi-Directional
Poly Pro Rejuv
Model 1600B
POLY Go
Express Tan
UV Biotek Mobile Lite and Versa Lite
Model 800B
Model 2400B
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device