Data / Medical devices / United States / Strata Skin Sciences, inc.
Strata Skin Sciences, inc.: FDA-registered device maker in Carlsbad, CA, United States, 6 510(k) clearances
Strata Skin Sciences, inc. is registered with the FDA (registration 2031934) in Carlsbad, CA, United States. It lists 2 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 14, 2020. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2031934
- FEI number
- 3002942014
- Address
- 2375 Camino Vida Roble Suite B, Carlsbad, CA, United States, 92011
- Owner or operator
- STRATA Skin Sciences, INC. (9036949)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- July 22, 2015
- Registered through
- 2027
- Brand names listed
- TheraClear, TheraClearX, Theraclear, VTRAC EXCIMER LAMP SYSTEM, XTRAC, XTRAC AL10000 Momentum, XTRAC Excimer Laser Phototherapy System, XTRAC Excimer Laser Phototherapy System Model No. AL10000 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 14, 2020 | K193478 | XTRAC Momentum Excimer Laser System | GEX | Substantially Equivalent | Strata Skin Sciences, Inc. | accessdata.fda.gov |
| March 4, 2013 | K123889 | ACLEARA, THERACLEAR | ONF | Substantially Equivalent | Theravant Corporation | accessdata.fda.gov |
| July 8, 2010 | K101415 | THERACLEAR | GEX | Substantially Equivalent | Theravant Corporation | accessdata.fda.gov |
| March 5, 2008 | K073659 | XTRAC ULTRA 2, MODEL AL10000 | GEX | Substantially Equivalent | Photo Medex, Inc. | accessdata.fda.gov |
| August 9, 2005 | K051428 | VTRAC EXCIMER LAMP SYSTEM | GEX | Substantially Equivalent | Photo Medex, Inc. | accessdata.fda.gov |
| October 14, 2004 | K041943 | XTRAC XL, MODEL AL8000 | GEX | Substantially Equivalent | Photo Medex, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 23, 2017 | 76697 | Class II | Terminated | XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma. | When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing. | accessdata.fda.gov |
| April 2, 2015 | 71127 | Class II | Terminated | MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection. | The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement). | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Updated January 14, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.