Dalphene Index

How often aesthetic devices are cleared, month by month

Updated Jul 26, 2026

Every month in the window including the partial edges, plus the product-code, submission-type and applicant-country splits.

Clearance cadence

11 full monthsmethod →

Narrow (unambiguously aesthetic) codes

clearances per month

05101520Aug2025Sep16OctNovDecJan2026FebMarAprMay9Jun
510(k) clearances per full month, narrow codes, by category
Lasers & LightBody ContouringSkin & TopicalsRF & MicroneedlingTotal
Aug60028
Sep60017
Oct1300316
Nov60006
Dec1130014
Jan40015
Feb31015
Mar70029
Apr21014
May42017
Jun90009

510(k) decisions per month in unambiguously aesthetic codes — filing tempo, not adoption.

Every month in the window

13 months · 11 completemethod →

510(k) decisions per month in the tracked aesthetic product codes, including the two partial edge months of the fetch window.

MonthLasers & LightBody ContouringSkin & TopicalsRF & MicroneedlingNarrow-code totalNarrow codesThe FDA device codes on this site that describe unmistakably aesthetic equipment, so counts built from them leave out general-purpose surgical kit.All tracked codesBroad codesFDA device codes that cover mixed uses, where aesthetic equipment shares a code with general medical equipment.Complete month?
Jul 2025100015Partial
Aug 20256002819Full month
Sep 20256001718Full month
Oct 2025130031636Full month
Nov 20256000622Full month
Dec 2025113001421Full month
Jan 20264001516Full month
Feb 20263101514Full month
Mar 20267002922Full month
Apr 20262101415Full month
May 20264201719Full month
Jun 20269000921Full month
Jul 2026100123Partial

The two edge months are partial by construction and are marked, not hidden and not scaled up.

By product code

16 codes with a decisionmethod →

Each bar is one FDA product codeProduct codeA three-letter FDA code naming a type of device rather than a brand, so every submission for that type of device carries the same code., not a device. Under it: the FDA's own name for that type of device, then whether this Index treats the code as narrow or as broad and mixed-use.

510(k) decisions per product code, 2025-07-25 to 2026-07-25

clearances

GEX is the largest bar at 73 clearances, 32% of the 231 shown, while the 3 smallest bars each show 1.

GEXPowered Laser Surgical Instrument · broad, mixed-use73
GEIElectrosurgical, Cutting & Coagulation & Accessories · broad, mixed-use58
OHSLight Based Over The Counter Wrinkle Reduction · narrow39
OHTLight Based Over-The-Counter Hair Removal · narrow18
OAPLaser, Comb, Hair · narrow8
NGXStimulator, Muscle, Powered, For Muscle Conditioning · broad, mixed-use7
PBXMassager, Vacuum, Radio Frequency Induced Heat · narrow6
OLIFat Reducing Low Level Laser · narrow5
QAIPowered Microneedle Device · narrow5
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect · narrow3
OLPOver-The-Counter Powered Light Based Laser For Acne · narrow2
ONGPowered Laser Surgical Instrument With MicrobeamFractional Output · narrow2
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction · narrow2
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption · narrow1
PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis · narrow1
SGTElectromagnetic Stimulator For Healthy Muscle Stimulation · narrow1
510(k) decisions per FDA product code over the fetch window
Clearances
GEX73
GEI58
OHS39
OHT18
OAP8
NGX7
PBX6
OLI5
QAI5
ONF3
OLP2
ONG2
PAY2
OHV1
PDZ1
SGT1

Product codes, not devices: one clearance sits under exactly one code, and some codes are shared with non-aesthetic medicine.

By submission type

231 decisionsmethod →

510(k) submission type

clearances

Traditional is the largest bar at 203 clearances, 88% of the 231 shown, while the smallest drawn, Abbreviated, shows 1.

Traditional203
Special27
Abbreviated1
510(k) decisions by submission type over the fetch window
Clearances
Traditional203
Special27
Abbreviated1

Which 510(k) route the submission took — a process fact, not a quality signal.

By applicant country

16 countriesmethod →

Applicant country on the 510(k) record

clearances

CN is the largest bar at 105 clearances, 45% of the 231 shown, while the 2 smallest bars each show 2.

CN105
US58
KR26
DE8
IL8
CA4
ES4
IT4
NL3
TW3
BR2
JP2
Other countries (4)FR 1 · GB 1 · IE 1 · IN 14
510(k) decisions by the applicant's country code
Clearances
CN105
US58
KR26
DE8
IL8
CA4
ES4
IT4
NL3
TW3
BR2
JP2
Other countries (4)4

The country on the APPLICANT's address — not where a device is made, and not where it is sold.