FDA Registration
Active
🇺🇸 United States
DERMATECH INNOVATIONS LLC
Reg #: 3020900954
·
FEI: 3020900954
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
1
Classifications
6
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Registration Details
- Registration Name
- DERMATECH INNOVATIONS LLC
- Registration Number
- 3020900954
- FEI Number
- 3020900954
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 10275 Collins Ave Apt 615
- City
- Bal Harbour
- State
- FL
- ZIP
- 33154
- Country
- US
Regulatory Submissions
- 510(k) Number
- K250830
Owner / Operator
- Firm Name
- DERMATECH INNOVATIONS LLC
- Operator Number
- 10095175
- Address
- 10275 Collins Ave # 615
- City
- Bal Harbour
- State
- FL
- Postal Code
- 33154
- Country
- US
- Correspondent
- ILAM M OHAYON
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2026-02-03 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2026-02-03 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2026-02-03 |
| Laser, Comb, Hair | OAP | Class 2 | Physical Medicine | No | 2026-02-03 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2026-02-24 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-02-03 |
Proprietary Names
Laser Mask
Beauty Eye Instrument D118, Hot & Cold Skin Care Device D829
Laser, comb, hair
Dermatech HIFU System
Medical Diode Laser Hair Removal System
DPL Skin Rejuvenation Beauty Instrument; LED Facial Mask; LED therapy light
M03; XZF-THE01;XZF-THE02;XZF-THE03;XZF-THE04;XZF-THE05;XZF-THE06;XZF-THE07;XZF-THE08;XZF-THE09;XZF-THE10;XZF-THE11;
; LED therapy mat; LED Light Therapy Device red light therapy panel Lamp, Infrared, Therapeutic Heating;
XZF-THE12; XZF-THE13;XZF-THE14;XZF-THE15
LED LIGHT THERAPY MASK; XZF-300 ,XZF-300-1, XZF-900, XZF-1500, XZF-1500pro, XZF-3000, XZF-5000, XFF-7000, SP-1103,
Establishment Types
Repack or Relabel Medical Device