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MMD Tip

Strata Skin Sciences, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Strata Skin Sciences, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K181480
Device name
MMD Tip
Company
Strata Skin Sciences, Inc.
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-06-05
Decision date
2018-08-01
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.

Intended Use

The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.

Device Description

The subject device is the Multi-Micro Dose ('MMD') Tip. The MMD Tip filters and reduces the laser output, providing four different dose levels in a single application. The reaction of the target area to the different dose levels assists in determining the patient specific Optimal Therapeutic Dose ('OTD'). The MMD Tip design places four (5mm x 5mm) square filters in the laser aperture.

Summary parsed at:2026-06-01 05:57:39 UTC

Predicate devices

1

K181480 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K181480 as a predicate